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Press Releases

November 28, 2023 – Inflammatix Receives Breakthrough Device Designation from FDA for TriVerity™ Acute Infection and Sepsis Test System2023-11-27T18:32:59-08:00

Regulatory Milestone Designed to Expedite Path to FDA Clearance and CMS Coverage.

Sunnyvale, Calif., November 28, 2023 — Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead product, the TriVerity™ Acute Infection and Sepsis Test System. The TriVerity Test System, currently under development, includes the Myrna™ Instrument and the TriVerity Test and is intended to be used in emergency departments in adult patients with suspected acute infection or suspected sepsis. The TriVerity Test is designed to provide three independent readouts that reflect the likelihood of a bacterial infection, the likelihood of a viral infection, and the risk of severe illness (based on the need for critical organ support* within seven days of presentation to the emergency department).

“We are pleased that the FDA has granted its Breakthrough Device Designation to TriVerity, as it reflects that this novel test system has the potential to help physicians improve on the current standard of care,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “By reaching this important regulatory milestone, we hope to place TriVerity on an accelerated pathway to FDA clearance, which would allow us to fill an unmet need for rapid, accurate tests for the diagnosis and prognosis of patients with suspected sepsis.”

The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization.

As a Breakthrough Device, TriVerity is expected to be eligible for the Centers for Medicare & Medicaid Services (CMS) New Technology Add-On Payment (NTAP) program, which will enable future Inflammatix hospital customers to receive a partial subsidy for purchases of TriVerity Acute Infection and Sepsis Tests performed on admitted patients for up to three years. In addition, assuming CMS finalizes its proposed Temporary Coverage for Emerging Technologies (TCET) rule, the TriVerity Test may be eligible for temporary coverage for tests run on discharged Medicare patients for up to four years. CMS is expected to issue its final ruling on TCET in December 2023.

“The potential Medicare reimbursement benefits associated with Breakthrough Designation may expedite implementation of TriVerity in our partner hospitals,” commented Dr. Sweeney. “We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch.”

* Defined as the need for mechanical ventilation, vasopressors, or renal replacement therapy.

 

About the TriVerity Acute Infection and Sepsis Test System

The TriVerity™ Acute Infection and Sepsis Test System, the lead product for Inflammatix, includes the Myrna™ Instrument and the TriVerity Test. The TriVerity Test incorporates a panel of 29 messenger RNAs (mRNAs) to “read” the body’s immune response, providing three readouts to facilitate diagnosis and prognosis of adult patients with suspected acute infection or sepsis that present in US emergency departments. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected acute infection.

The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 mRNAs from whole blood or other sample types in about 30 minutes. While the first version of the Myrna Instrument will require standard laboratory operation, the company’s roadmap includes the development of a Clinical Laboratory Improvement Amendments (CLIA)-waivable version to enable point-of-care deployments.

The company recently announced the completion of technical development for the TriVerity Test System and has resumed its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for 510(k) clearance of the TriVerity Test System by the FDA. The multi-center study has already enrolled 955 of the estimated 1,500 patients targeted. The company estimates study completion and FDA submission to occur in 2024.

The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

About Inflammatix

Inflammatix, Inc., a pioneering molecular diagnostics company headquartered in Sunnyvale, California, USA, is developing novel diagnostics that rapidly read a patient’s immune system to improve patient care and reduce major public health burdens. The Inflammatix tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc).

Inflammatix product development has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.

TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the US and other countries and regions.

Media Contact

Reba Auslander, RAliance Communications
917-836-9308
[email protected]

Inflammatix device with cartridge

The TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument and TriVerity Cartridge, has reached a regulatory milestone designed to expedite the path to FDA clearance and CMS coverage .

November 15, 2023 – Inflammatix Completes Technical Development for TriVerity™ Acute Infection and Sepsis Test System2023-11-14T17:02:04-08:00

Company Reaches Important Product Development Milestone with its Myrna™ Instrument and TriVerity Cartridge.

Sunnyvale, Calif., November 15, 2023  — Inflammatix, Inc., a pioneering molecular diagnostics company, announced today that the company has completed technical development for its TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument, and for the TriVerity™ Cartridge. TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).

“Myrna will be the world’s highest-multiplex point-of-care system capable of quantitating RNA, allowing us to bring ‘precision medicine’ into acute care settings,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “Completing technical development brings TriVerity a step closer to FDA submission and launch, and enables us to execute key clinical studies.”

The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 messenger RNAs (mRNAs) from whole blood or other sample types in about 30 minutes. It is designed to be Clinical Laboratory Improvement Amendments (CLIA)-waivable to enable point-of-care deployments. The disposable cartridges are expected to be room-temperature stable for up to 12 months.

“With the completion of the test system, we look forward to further exploring partnerships that bring existing RNA signatures onto the Myrna ecosystem,” Dr. Sweeney commented. “This may be an especially viable pathway given expected changes to the regulation of lab-developed tests and the increased reliance on a biomarker-driven approach to immunotherapy development.”

The TriVerity Acute Infection and Sepsis Test, Inflammatix’s lead product, incorporates a panel of 29 mRNAs to ”read” the body’s immune response and thus aid in the diagnosis of patients with suspected acute infection and sepsis. It is designed to potentially facilitate diagnosis of patients with suspected infection that present in US emergency departments. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected infection.

The company has resumed completion of its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for submission of the TriVerity Test system to the U.S. Food and Drug Administration (FDA). The multi-center study has already enrolled 955 of the estimated 1,500 patients needed. Inflammatix estimates study completion and FDA submission to occur by spring 2024.

The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.

About Inflammatix

Inflammatix, Inc., is an innovative molecular diagnostics company based in Sunnyvale, California, USA, that is developing novel diagnostics that rapidly read a patient’s immune system to improve patient care and reduce major public health burdens. Inflammatix’s tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc).

Inflammatix product development has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.

Myrna, TriVerity, and Inflammatix are trademarks of Inflammatix, Inc. in the US and other countries and regions.

Media Contact

Reba Auslander, RAliance Communications
917-836-9308
[email protected]

Inflammatix device with cartridge

The TriVerity™ Acute Infection and Sepsis Test System, which includes the Myrna™ Instrument and TriVerity Cartridge, has reached an important milestone with completion of technical development.

September 13, 2023 – UMCG and Inflammatix Collaborate to Improve Early Recognition and Clinical Decision Support for Sepsis Care2023-09-18T10:56:01-07:00

Data-biobank Acutelines and Inflammatix, an innovative molecular diagnostics company, are joining forces to improve the early detection of sepsis: a potentially fatal syndrome caused by a dysregulated immune response to infection.

Sunnyvale, Calif., September 13, 2023  — Acutelines and Inflammatix are developing a smart tool to facilitate recognition of sepsis and support clinical decisions in the early phase of the disease. Early recognition of sepsis is hard but can make a significant impact on patient outcomes.

The importance of early recognition
Before the COVID-19 pandemic, annually, 50 million patients were diagnosed with sepsis. The pandemic has led to a steep increase in these numbers. Early recognition of infections and accurate differentiation between viral and bacterial etiology is vital to select effective therapy. On the one hand, each hour of delayed antibiotic treatment introduces additional risk for bacterial infection patients. On the other hand, rampant overuse of antibiotics drives the development of antimicrobial-resistant (AMR) bacteria, risking the effectiveness of current antibiotics.

Recent estimates indicate nearly 5 million deaths associated with AMR. Novel precision diagnostic approaches can support balancing the tightrope between overtreating the uninfected and missing the infected patients, thereby impacting society by improving patient outcomes and reducing the socioeconomic burden of sepsis and AMR.

Improving the future of sepsis
The project will approach this diagnostic dilemma by combining health records and biological information with the goal to deliver better clinical decision support for patients with suspected sepsis visiting the emergency department. Blood samples will be collected, and the expressions of genes associated with the immune response to infection will be measured. These biological signals along with clinical record data collected during the patient encounter will be used to derive diagnostic algorithms that can better inform on the presence, type and severity of infection. These signatures will be validated in prospective studies and are planned to be used by physicians to better recognize early sepsis, decide whom to admit and when to administer antibiotics.

Data-biobank Acutelines ensures availability and standardized processing of data and biomaterials from more than five thousand samples from over one thousandpatients. Inflammatix brings expertise in developing machine learning-based algorithms and building rapid point-of-care-based gene expression diagnostics into the collaboration.

Integrating health data in a clinically actionable manner
“Our collaboration will allow us to leverage our expertise in data-banking and research to better understand the dynamics of sepsis. Inflammatix’s proficiency in machine learning and rapid gene expression diagnostics will greatly enhance our efforts to develop a smart, early diagnosis system,” says Dr. Hjalmar Bouma, project leader of Acutelines. Dr. Timothy Sweeney, CEO and co-founder of Inflammatix, added, “Our joint efforts with Acutelines accelerates our mission to further improve sepsis diagnosis by integrating health record data with our biological signature in a clinically actionable manner. ”

Support
The project is supported by Health Holland through a public-private partnership allowance. This support underscores a shared commitment to advancing healthcare and improving patient outcomes. The Acutelines-Inflammatix partnership marks a significant step forward in early sepsis diagnosis, ultimately paving the way towards precision medicine and saving lives.

About Acutelines and Inflammatix

About Acutelines
Acutelines is a leading data-biobank based in the Acute and Emergency Department at University Medical College Groningen (UMCG). Acutelines is committed to improving acute care by developing smart diagnostics and personalized medicine.

About Inflammatix
Inflammatix, Inc., is an innovative molecular diagnostics company based in Sunnyvale, California, USA, developing novel diagnostics that rapidly read a patient’s immune system to improve care and reduce major public health burdens. Inflammatix tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care.

July 10, 2023 – Inflammatix Appoints Heiner Dreismann as New Board Member2023-07-17T09:38:19-07:00

Sunnyvale, Calif., July 10, 2023  — Inflammatix, a pioneering molecular diagnostics company, announced today the appointment of Heiner Dreismann, PhD, as a member of the company’s board of directors.

Dr. Dreismann brings to Inflammatix more than 35 years of experience in the life sciences and health care industries and is regarded as a pioneer in the early adoption of polymerase chain reaction (PCR) technique, one of the most ubiquitous technologies in molecular biology and genetics research today. He was CEO of Roche Molecular Systems from 2000-2006 after various leadership roles in Roche’s global Diagnostic Division. Besides Inflammatix, Dr. Dreismann currently serves on several boards of public, private, and non-profit organizations.

“We are thrilled to welcome Dr. Dreismann to the Board. We envision host response-based diagnostics to become ubiquitous as did PCR and couldn’t think of a better person to guide us on our journey. In addition to understanding how to be launch groundbreaking technology, we plan to leverage Heiner’s executive, board and technical experiences to inform strategic decisions as we approach commercialization,” said Inflammatix CEO and Co-Founder Timothy Sweeney, MD, PhD.

Dr. Dreismann commented, “I am so impressed by the Inflammatix approach of immune-based diagnostics, and with the extensive data published to date. Host response diagnostics are poised to finally address significant unmet needs in acute infections, sepsis, and other conditions. I’m excited to help Inflammatix bring their important products to patients worldwide.”

About Inflammatix

Inflammatix, Inc., is an innovative molecular diagnostics company developing novel diagnostics that rapidly read a patient’s immune system to improve care and reduce major public health burdens. The company’s initial focus is acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The Sunnyvale, California-based company is backed by top-tier investors including Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, the Stanford StartX Fund, and OSF Ventures.

June 15, 2022 – Inflammatix Appoints Dr. Purvesh Khatri as Chief Scientific Officer2022-06-15T07:48:51-07:00

Burlingame, Calif., June 15, 2022  — Inflammatix, Inc., a pioneering molecular diagnostics company, announced today the appointment of Purvesh Khatri, PhD, as Chief Scientific Officer. As a co-founder of Inflammatix, Dr. Khatri had previously served as a Scientific Advisor to the company while serving as Associate Professor at Stanford University’s Institute for Immunity, Transplantation, and Infection.

Dr. Khatri possesses more than 15 years of experience in bioinformatics, computational biology, and translational medicine. He is well-known for his work on ontological and pathway analysis of high-throughput molecular, genomics, and proteomics data. Dr. Khatri developed the first ontology tool for analysis of microarray data, named Onto-Express, and has expanded into a suite of web-based open access tools, Onto-Tools.

His most recent work focused on developing computational methods for integrated, multi-cohort analysis of publicly available data to increase sample size, as well as better account for the heterogeneity observed in real world patient populations. Using these methods, he has identified highly specific and sensitive biomarkers for: (1) infectious diseases (sepsis, respiratory infections, tuberculosis), (2) acute solid-organ transplant rejection, and (3) cancer (pancreatic cancer, small cell and non-small cell lung cancer, mesothelioma). Dr. Khatri has authored or co-authored more than 140 papers and holds  30-plus patents.

“Purvesh is a world leader in using complex clinical and biological datasets to develop new diagnostic, prognostic and predictive models, and new therapeutic insights. He has been with us since day one, and we are thrilled to bring him onboard full-time to lead our scientific teams through ever-greater discoveries and translational breakthroughs,” said Inflammatix CEO and Co-Founder Timothy Sweeney, MD, PhD.

Dr. Khatri added, “I am excited to make a full-time commitment to Inflammatix as it continues its work to address important unmet needs in the diagnosis of acute illness. The team has made a great deal of progress since we founded the company, and I am delighted to join them in their next phase of growth and discovery. I am confident that we will continue to innovate to improve upon current diagnostic methods and enable the highest level of patient care possible.”

About Inflammatix

Inflammatix, Inc., is an innovative molecular diagnostics company developing novel diagnostics that rapidly read a patient’s immune system to improve care and reduce major public health burdens. The company’s initial focus is acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform, enabling the power of precision medicine at the point of care. The Redwood City, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, the Stanford StartX Fund, and OSF Ventures.

Media Contact

Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274

November 30, 2021 – Inflammatix Appoints Dr. Kian Beyzavi as New Board Member2021-11-30T08:12:01-08:00

Burlingame, Calif., November 30, 2021  — Inflammatix, a pioneering molecular diagnostics company, announced today the appointment of Kian Beyzavi, PhD, as an independent member of the company’s board of directors.

Dr. Beyzavi is a seasoned veteran of the healthcare industry with significant operating experience in the medical device and diagnostics industries, and a focus on leveraging innovative technologies to improve diagnosis and delivery of care. Since starting her career at McKinsey & Company, she has over 25 years of experience as a venture investor, entrepreneur, consultant, and general manager at Rho Ventures, Cubit Software, Medtronic, Abbott Diabetes Care and Novartis Diagnostics. Through her work with multiple stakeholders, Kian has developed a systems-level view of the complex healthcare ecosystem. For the past 10 years she has led a specialized consulting firm advising Fortune 500 companies, startups and others in the areas of strategy, product development, business model innovation, commercialization, and monetization of novel opportunities across life sciences. She is currently a venture partner at Cota Capital, a multistage investment firm.

“We are delighted to welcome Kian to the board. She brings a wealth of vision and deep commercialization experience across diagnostics to her new role with the company. We are drawn to her commitment to leverage technology in improving healthcare and are eager to tap into her insights as we utilize AI and genomics in our mission to improve the diagnosis of infection,” said Inflammatix CEO and Co-Founder Timothy Sweeney, MD, PhD.

Dr. Beyzavi added, “I’m thrilled to join the board. Inflammatix is poised to address important unmet needs in the diagnosis of acute illness, which will result in improved treatment decisions and outcomes. I look forward to working with this innovative team as they bring their breakthrough technologies to market.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, CA-based company is funded by leading medical technology investors including Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, and others. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contact

Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274

November 18, 2021 – Inflammatix Announces Additional $12.1 Million Funding from BARDA for ViraBac EZ Acute Infection Test2021-11-18T09:36:33-08:00

Third Tranche of BARDA Funding Supports Diagnostic Designed to Read Immune System and Rapidly Diagnose Acute Infection at Point of Care

Burlingame, Calif., November 18, 2021  — Inflammatix, a pioneering molecular diagnostics company, announced today a contract extension of $12.1 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The funding is part of a BARDA contract worth up to $72 million if all options are exercised.

The new funding will be used for continued development and clinical studies to support FDA clearance of the ViraBac EZTM test, which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral. ViraBac EZ is intended to help physicians quickly and accurately determine whether to prescribe antibiotics in ambulatory settings. The test will use a capillary blood sample, ideal for use in primary care, urgent care and other outpatient clinical settings. The funding also supports development of the sample-to-answer, point-of-care system on which ViraBac EZ, and all Inflammatix’s tests, are run. The system is designed to read mRNA and analyze the results using a machine learning algorithm to produce answers in less than 30 minutes.

One of the biggest threats to global health today is antibiotic resistance. Increasing and incorrect antibiotic use leads to antibiotic-resistant bacteria that become more difficult and costly to treat, and more deadly. Today, an estimated 30 percent of antibiotics are inappropriately prescribed to patients because their infections are not obviously bacterial or viral in origin.1  In addition, almost three million Americans each year become infected with bacteria that are resistant to antibiotics, with more than 35,000 dying as a direct result.2  New diagnostic methods that can help better direct antibiotics to only those patients that need them will be an important element in combatting antibiotic resistance, ensuring that proven therapies can continue to fight disease and save lives.

“We are enthusiastic about developing a test with the potential to play a large role in addressing antibiotic resistance and ensuring the right medicine gets to the right patients,” said Tim Sweeney, M.D., Ph.D., co-founder and chief executive officer of Inflammatix. “With ViraBac EZ and all of our tests, we are integrating diverse patient cohorts in product development to ensure that our tests will perform in real-world practice across multiple clinical settings, from doctor’s offices and outpatient clinics to the emergency room. This approach is important because the patient response to infection can vary. To successfully change clinical practice, a test must be robust enough to use in different types of patients, infections, and clinical contexts.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, California based company is funded by Khosla Ventures, Northpond Ventures, D1 Capital Partners, and Think.Health Ventures, among others. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50119C00034.

References

  1. Hersh AL, King LM, Shapiro DJ, Hicks LA, Fleming-Dutra KE. Unnecessary antibiotic prescribing in US ambulatory care settings, 2010-2015. Clin Infect Dis. 2020; ciaa667, org/10.1093/cid/ciaa667.
  2. Antibiotic/Antimicrobial Resistance. U.S. Centers for Disease Control and Prevention website. Updated July 20, 2020. Accessed October 7, 2020. https://www.cdc.gov/drugresistance/index.html.

Contacts

Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274

November 11, 2021 – Inflammatix Awarded $1.7 Million Grant From National Institutes of Health (NIH)2021-11-11T09:32:24-08:00

Funding Will Support Groundbreaking Development of Sepsis Endotypes Test

Burlingame, Calif., November 11, 2021  — Inflammatix, a pioneering molecular diagnostics company, announced today that the National Institute of General Medical Sciences, part of the National Institutes of Health, has awarded the company a Small Business Innovation Research (NIH SBIR) Direct-to-Phase II grant of $1.7 million. The funding will be used to develop a rapid diagnostic that will identify immune subtypes (“endotypes”) of sepsis to enable better therapy selection and resource allocation.

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host immune response to infection. While over 100 clinical trials have been conducted attempting to modulate the immune response to sepsis, there have been no successful approvals of immunomodulatory therapies. Before COVID-19, sepsis claimed approximately 270,000 lives each year in the U.S. and was estimated to be responsible for 20 percent of all deaths worldwide. Severe COVID-19 is also a form of sepsis.

“In sepsis, the body’s immune system becomes dysregulated and starts to damage the patient directly. For decades, physicians have hoped that modulating the immune response to sepsis would improve outcomes, but this hasn’t yet come to pass. We believe that patients with sepsis are too variable for a ‘one-size-fits-all’ approach to therapy and have shown that identifying immune subtypes of sepsis may allow for a precision approach to treatment,” said Inflammatix CEO and Co-Founder Tim Sweeney, MD, PhD.

He continued, “Fifty years ago, cancer was known primarily by anatomy: breast, skin, blood. The advancement of precision medicine has brought an understanding of each cancer’s unique molecular profile, which has unlocked revolutionary therapies and driven improvements in survival. We believe that critical illness, and sepsis in particular, can benefit from the same approach. We are grateful for the support from the NIH for our novel approach, which may allow the medical community to identify improved treatment regimens, leading to the discovery of new targets or pathways for endotype-specific therapies and/or the repurposing of available drugs. Our ultimate goal is to definitively link a patient sepsis subtype with a therapeutic intervention, to make a meaningful improvement in the treatment of sepsis globally.”

The company’s work has identified three unique sepsis subtypes (“endotypes”) using host immune mRNA signatures, and these endotypes may be differentially responsive to therapy. The NIH funding will enable further development of the endotypes signature and development of a rapid, 30-minute test on the company’s proprietary point-of-care system. Further work will identify existing or new therapeutics that match to the endotypes for clinical study. The company is actively working with therapeutics partners on this approach.

The Inflammatix approach – known as host-response diagnostics – rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm. The company is developing other host-response diagnostic tests that identify the presence and type of infection (viral or bacterial) and predict the risk of severe disease, which could enable physicians to make more informed decisions for patients with acute infection and sepsis. All tests will run on the company’s cartridge-based, point-of-care system in under 30 minutes.

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, CA-based company is funded by leading medical technology investors including Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, and others. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Contacts

Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274

March 16, 2021 – Inflammatix Secures $102 Million in Series D Financing Led by D1 Capital Partners to Commercialize Novel Host Response Diagnostics2021-03-16T13:36:47-07:00

Burlingame, Calif., March 16, 2021  — Inflammatix, a pioneering molecular diagnostics company, announced today the closing of a $102 million Series D round of financing to support development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with participation from the company’s existing investors, including Northpond Ventures, Khosla Ventures, Think.Health, and OSF Healthcare Ventures.

“We are thrilled to welcome D1 Capital Partners to our strong investor syndicate, and look forward to bringing host response diagnostics to market”

Sepsis caused more than five million deaths annually worldwide before the COVID-19 pandemic, and severe COVID-19 has been recognized as viral sepsis. In addition, antibiotic resistance is directly responsible for more than 700,000 deaths annually worldwide. Traditional methods for diagnosing acute infections are slow and are often inaccurate because they only look for pathogens in the bloodstream, despite the fact that most infections never enter the bloodstream. As a result, patients with suspected infection are often inappropriately treated with antibiotics, contributing to antibiotic resistance. Sepsis is often missed altogether.

Inflammatix’s diagnostics rapidly read the patient’s immune response to infections across multiple mRNA biomarkers using machine learning algorithms. The company’s tests can identify the presence and type of infection (viral or bacterial), and the risk of severe disease, including severe COVID-19, to enable physicians to make more informed decisions. The tests are designed to be run on the company’s sample-to-answer, cartridge-based, point-of-care Myrna™ test system, which produces results in under 30 minutes.

The funds will enable regulatory clearance and global commercialization of the Myrna system, and the InSep™ acute infection and sepsis test, which is designed to enable improved triage and decision-making in the emergency department and other acute care settings. Funds will also support continued development of the company’s pipeline of diagnostic tests, including the ViraBac EZ™ acute infection test. Virabac EZ is designed to be run from a simple fingerstick to identify whether a suspected infection is bacterial or viral, helping physicians in primary care, urgent care, and other outpatient clinical settings to determine when to prescribe antibiotics.

“We are enthusiastic about the transformative potential of Inflammatix’s host response diagnostic approach to significantly improve two major issues in healthcare today: the inefficient, and often inaccurate, diagnosis of infection and sepsis, and the over-prescription of antibiotics,” said James Rogers, Analyst at D1 Capital Partners. “We are delighted to lead this round and look forward to the upcoming commercialization of the first of these novel tests, and to playing a role in the continued development of additional indications for this unique diagnostics approach.”

“We are thrilled to welcome D1 Capital Partners to our strong investor syndicate, and look forward to bringing host response diagnostics to market,” said Inflammatix CEO and Co-Founder Tim Sweeney, M.D., Ph.D. “By quickly providing actionable information about disease, Inflammatix expects to equip physicians to make better clinical decisions that benefit both patients and healthcare systems.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform, Myrna, in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, D1 Capital Partners, Think.Health Ventures, the Stanford StartX Fund, and OSF Ventures.

ViraBac EZ has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.

About D1 Capital Partners

D1 Capital Partners is a global investment firm that operates across public and private markets. The firm combines the talent and operational excellence of a large, premier asset management firm with the flexible mandate and long-term time horizon of a family office. Founded in 2018 by Daniel Sundheim, D1 focuses on investing in the global internet, technology, telecom, media, consumer, healthcare, financial, industrial, and real estate sectors.

Contacts

Michelle McAdam, Chronic Communications, Inc.
[email protected]
310.902.1274

Mariesa Kemble
[email protected]
608.850.4745

October 29, 2020 – Inflammatix Announces $7.4 Million in Additional BARDA Funding to Advance ViraBac EZ Acute Infection Test2021-03-16T11:25:52-07:00

Second Tranche of BARDA Funding Supports Diagnostic Designed to Read Immune System and Rapidly Diagnose Acute Infection at Point of Care

Burlingame, Calif., October 29, 2020  — Inflammatix a pioneering molecular diagnostics company, announced today a contract extension of $7.4 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its point-of-care test and system to diagnose infection by reading the immune system. The contract is part of a BARDA contract worth up to $72 million, if all options are exercised.

The new funding will support continued development and commercialization of Inflammatix’s sample-to-answer, point-of-care MyrnaTM test system, which is designed to read RNA using machine learning and produce results in under 30 minutes, as well as continued development of the ViraBac EZTM test (formerly known as HostDx Fever), which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine when to prescribe antibiotics. The test will use a fingerstick collection and capillary blood sample, and is designed for use in primary care, urgent care and other outpatient clinical settings.

One of the biggest threats to global health today is antibiotic resistance. Increasing and incorrect antibiotic use leads to antibiotic-resistant bacteria that become more difficult and costly to treat, and more deadly.  Today, an estimated 30 percent of antibiotics are inappropriately prescribed to patients because their infections are not obviously bacterial or viral in origin.1  In addition, almost three million Americans each year become infected with bacteria that are resistant to antibiotics, with more than 35,000 dying as a direct result.2  New diagnostic methods that can help better direct antibiotics to only those patients that need them will be an important element in combatting antibiotic resistance, ensuring that proven therapies can continue to fight disease and save lives.

“We are pleased to continue to partner with BARDA in the development of our ViraBac EZ test and Myrna instrument. Enabling physicians to make more informed decisions about which patients need antibiotics and which can avoid them has the potential to transform patient care at the point of care,” said Tim Sweeney, M.D., Ph.D., co-founder and chief executive officer of Inflammatix.

“In the physician’s office, current methods for diagnosing infections are slow, produce inconsistent results, and/or do not provide the information we need to confidently prescribe treatment,” said David Lin, MD, family medicine specialist with Sutter Health, Sacramento, California. “Having a test that allows us to quickly make more informed decisions about which patients are infected and could benefit from antibiotics would have a meaningful impact on patient care.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford StartX Fund, Think.Health Ventures, and OSF Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.

References

  1. Hersh AL, King LM, Shapiro DJ, Hicks LA, Fleming-Dutra KE. Unnecessary antibiotic prescribing in US ambulatory care settings, 2010-2015. Clin Infect Dis. 2020; ciaa667, org/10.1093/cid/ciaa667.
  2. Antibiotic/Antimicrobial Resistance. U.S. Centers for Disease Control and Prevention website. Updated July 20, 2020. Accessed October 7, 2020. https://www.cdc.gov/drugresistance/index.html.

Media Contacts

For Inflammatix:
Mariesa Kemble
[email protected]
608.850.4745

September 29, 2020 – DARPA Awards Inflammatix up to $1.1 Million to Develop Diagnostic that Predicts COVID-19 Severity Risk2020-09-29T05:09:46-07:00

New Data Shows Inflammatix Machine Learning-Based Approach of Reading Immune System is Superior to IL-6 and Other Measures in Predicting Patients at High Risk for Severe COVID-19

Burlingame, Calif., September 29, 2020  — Inflammatix a pioneering molecular diagnostics company, announced today that the Defense Advanced Research Projects Agency (DARPA) has awarded the company up to $1.1 million for further development of a rapid diagnostic that reads the immune system to predict severe respiratory failure risk in COVID-19 patients. The diagnostic is being developed to help physicians make better hospital admission and resourcing decisions for COVID-19 patients at hospital presentation.

The Inflammatix approach – known as host-response diagnostics – rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm. The company is developing other host-response diagnostic tests that identify the presence and type of infection (viral or bacterial), in addition to predicting the risk of severe disease, to enable physicians to make more informed decisions for patients with acute infection and sepsis.

“We are grateful that DARPA has recognized the promise of our host-response approach to benefit COVID-19 patients and caregivers, and we look forward to accelerating development and availability of our CoVerityTM COVID-19 Severity Test as a result of this agreement,” said Inflammatix CEO and Cofounder Tim Sweeney, MD, PhD. “The 5-mRNA classifier for CoVerity was developed on a training set of more than 20 clinical studies and we intend to translate it into a rapid assay that can be used as a clinical tool to help triage patients after diagnosis with COVID-19. Improved triage has the potential to reduce morbidity and mortality while enabling hospitals to allocate resources more effectively.”

The company’s host-response diagnostic approach for predicting COVID-19 severity risk was shown to be superior to clinical biomarkers, including IL-6, in a new study presented last week at the 2020 European Society of Clinical Microbiology and Infection Diseases (ESCMID) Conference on Coronavirus Disease (ECCVID).

“While major progress has been made in developing rapid platforms to diagnose SARS-CoV-2 infection, predicting severity in COVID-19 patients remains an unmet medical need,” said Evangelos J. Giamarellos-Bourboulis, MD, Professor of Internal Medicine and Infectious Diseases at ATTIKON University General Hospital in Athens, Greece, Chairman of the European Sepsis Alliance, President of the European Shock Society, and lead investigator for the study. “In this study, the host-response approach demonstrated very high accuracy for identifying severe disease in COVID-19 patients and outperformed clinical markers for risk stratification. Existing tools have shown limited accuracy in enabling us to confidently identify high-risk patients early who need close monitoring or discharge non-severe patients to recover at home.”

In this prospective study of 97 patients with PCR-confirmed SARS-CoV-2 pneumonia and blood drawn on the day of admission at ATTIKON University General Hospital in Athens, Greece, CoVerity demonstrated an area under the receiver operating characteristic curve (AUROC) of 0.88 (95% CI 0.81-0.95) for identifying patients who developed respiratory failure or died, independent of age, while IL-6 had an AUROC of 0.73 (95% CI 0.62 – 0.85). The new classifier had the highest accuracy among all single biomarkers tested, including IL-6, procalcitonin, C-reactive protein, lactate, and SuPAR.

This agreement is part of DARPA’s efforts to develop platform technologies that can be deployed safely and rapidly to provide the U.S. population with near-immediate protection against emerging infectious diseases and engineered biological weapons, even in cases when the pathogen or infectious agent is unknown.

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by reading the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Future tests will be developed to run on the company’s sample-to-answer isothermal instrument platform, MyrnaTM, in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by leading medical technology investors including Khosla Ventures, Northpond Ventures, the Stanford StartX Fund, Think.Health Ventures and OSF Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Mariesa Kemble
[email protected]
608.850.4745

April 28, 2020 – Study Demonstrates Substantial Cost Savings in Health Economic Model of the Inflammatix Host-Response Test for Sepsis2020-04-29T07:19:00-07:00

Model Demonstrated Cost Effectiveness in Test Use on Patients Suspected of Acute Respiratory Tract Infections in American Emergency Department Setting

Burlingame, Calif., April 29, 2020 — Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, announced the publication of a health economic model that shows use of the company’s HostDxTM Sepsis test in patients suspected of acute respiratory tract infections (ARTI) in Emergency Departments is cost-effective versus standard-of-care. The study was published today in The Journal of Health Economics and Outcomes Research. The model informs hospital clinicians of the potential clinical and economic benefits of widespread adoption of the HostDx Sepsis test.

“Despite best intentions, current practices for evaluating patients suspected for acute respiratory tract infections are insufficient. Many patients without bacterial infections are overtreated with unnecessary antibiotics and extended hospital stays, while some patients with infections are missed, leading to dire clinical outcomes. This study shows that Inflammatix’s HostDx Sepsis test for the diagnosis of acute infections and sepsis could allow for improved patient outcomes and substantial health system savings” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix.

The publication described a cost impact model comparing the cost of standard of care versus the use of HostDx Sepsis in two hypothetical arms with 1000 patients presenting with symptoms of ARTI in the Emergency Department of an average US hospital. Compared to standard of care, on average, the HostDx Sepsis test arm showed a 0.80 day reduction in hospital ward length of stay (a 36.7% decrease), 1.49 reduction in days of antibiotic treatment (a 29.5% decrease), and a 1.67% decrease in 30-day mortality rate (a 13.64% decrease). Average cost savings were estimated at $1,974 per patient tested and nearly $2 million for the 1000-patient cohort (before considering the price of the HostDx Sepsis test, which has not yet been established).

For each scenario, standard of care and HostDx Sepsis, costs of treatment, hospitalizations, medications and outpatient visits were considered. HostDx Sepsis produces three scores for each patient: the likelihood of a bacterial infection; the likelihood of a viral infection; and risk stratification score. The HostDx Sepsis arm assumed the application of the test’s performance previously published in prospective clinical validation studies in the journals Science Translational Medicine1 and Nature Communications2,3. These included area under the receiver operating curve (AUROC) of 0.85 for the detection of a bacterial infection, 0.90 for the detection of a viral infection and 0.88 for predicting 30-day mortality (risk stratification).

“The ability to interrogate and understand how the immune system reacts to infection is more important than ever given the current COVID-19 pandemic. Whether it’s COVID-19, influenza, or bacterial infections, physicians need the ability to rapidly identify the presence, type, and severity of infection in a timely manner. Tests with robust performance characteristics that are generalizable are key to improving outcomes and reducing healthcare costs,” continued Sweeney.

Sepsis leads to 270,000 deaths4 in the US and $27B in Medicare costs5 annually. Inflammatix’s HostDx Sepsis test uses proprietary machine learning algorithms that incorporate the expression of multiple immune genes (host response) to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. Inflammatix’s simple-to-use, sample-to-answer HostDx system is designed to produce results at or near the point of care in 30 minutes or less. The company plans to advance its HostDx tests through commercial launch in Europe and submission to the United States Food and Drug Administration in 2021.

In January 2020, Inflammatix announced it had received $32 million in Series C financing. Prior to that, in November 2019, the company announced a cost-sharing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx tests. The agreement is worth up to $72 million based on achieving certain milestones.*

Citation

Schneider JE, Romanowsky J, Schuetz P, Stojanovic I, Cheng HK, Liesenfeld O, et al. Cost impact model of a novel multi-mRNA host response assay for diagnosis and risk assessment of acute respiratory tract infections and sepsis in the emergency department. JHEOR. 2020;7(1):24-34. doi:10.36469/jheor.2020.12637

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

#  #  #

Media Contact:

Jonathan Romanowsky

[email protected]

(650) 219-2141

April 16, 2020 – Inflammatix Appoints João Fonseca, Ph.D., as Chief Technology Officer2020-04-16T08:32:18-07:00

Burlingame, Calif., April 16, 2020 — Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, today announced the appointment of João Fonseca, Ph.D., as Chief Technology Officer. Dr. Fonseca will oversee Inflammatix’s molecular assay development and engineering teams as the company advances its rapid tests for acute infections, sepsis, and COVID-19 risk stratification.

“João is an exceptional scientist and executive with a successful track record for building breakthrough diagnostics products, particularly at the point of care,” said Tim Sweeney, Ph.D., cofounder and chief executive officer of Inflammatix. “He will play a critical role in bringing our novel tests to the clinic where they will help physicians take the guesswork out of determining which patients with infections need antibiotics, as well as which are likely to have or develop sepsis. He will also oversee our COVID-19 product development portfolio.”

Dr. Fonseca comes to Inflammatix with extensive credentials in science and medical technology. Since 2006, he has served as founder, CEO and chief scientific officer of biosurfit, a Lisbon, Portugal-based company whose blood tests utilize proprietary technology to diagnose multiple conditions at the point of care. The company’s tests are broadly available throughout Europe. Prior to biosurfit, Dr. Fonseca was a professor in physics and experimental physics at the Technical University of Lisbon and a researcher at the University of Lisbon. He also founded a non-profit organization that works with patients and researchers to advance novel cancer treatments and research. Dr. Fonseca has authored multiple publications in top peer-reviewed journals, is the author of 22 patents and has received numerous awards, including “Entrepreneur of the Year” by the Portuguese Young Entrepreneur Association.

“I’m excited to join Inflammatix in their mission of harnessing the immune system to tackle some of the world’s most pressing public health challenges, including antibiotic resistance and sepsis,” said Dr. Fonseca. “I look forward to helping the company deliver its rapid molecular tests into hospitals and clinics where they can benefit patients and to helping the company build a robust pipeline in additional clinical indications.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

#  #  #

Media Contact:

Jonathan Romanowsky

[email protected]

(650) 219-2141

March 18, 2020 – Leading Stanford Alumni Scientists and Physicians Launch StartX Med COVID-19 Task Force2020-03-19T16:58:44-07:00

Palo Alto, Calif., March 18, 2020  —  70+ StartX Med Innovators with Medical Breakthroughs for the Prevention, Diagnostics and Treatment of Coronavirus Mobilize Efforts to Fast-Track Public Health Needs During Pandemic StartX, a non-profit startup community of more than 1500 Stanford faculty and alumni founders, announces the launch of its StartX Med COVID-19 Task Force and the mobilization of its breakthrough medical companies providing solutions for the prevention, diagnostics and treatment of the novel coronavirus. The group of leading scientists, physicians and professor entrepreneurs will collaborate on outreach to government agencies, regulatory bodies and healthcare systems in the interest of public health.

Among the many leading-edge biotech, medical device and digital health companies solving critical needs during the COVID-19 pandemic are physicians working with positive cases, companies with FDA cleared solutions and those that are on the fast-track with the CDC. The following are a few ways the StartX Med COVID-19 Task Force is working to provide hope, flatten the curve, and combat the novel coronavirus:

  • Rapid tests suitable for drive through testing, nursing homes, and ER rooms with results in 10 minutes
  • Applications and hardware to assess respiratory issues
  • Rapid solutions to fight developing sepsis and correlating antibiotic resistance resulting from COVID-19 severe complications
  • COVID-19 related applications for remotely monitoring quarantined patients and healthcare workers who have been exposed
  • Rapid RNA testing technologies
  • Testing that provides information on the presence, type and severity of infections
  • Solutions for optimizing hospital operations and supply chain tracking
  • Solutions for automated quarantine management and remote virtual triage
  • A centrifuge system which is readily deployable for remote sample collection and prep
  • A handheld device measuring temperature, lung sounds, airway pressure, pulmonary function, ECG, and SPO2
  • Remote monitoring for respiratory diseases, and other StartX Med technologies already deployed in Wuhan, China
  • Free access to the Bioz research platform for biopharma companies
  • Free virtual COVID-19 evaluation, screening and escalation tool for any hospital in the U.S. to help preserve clinical resources for patients who warrant in-person care
  • StartX Med therapeutics companies with new antiviral drugs to treat COVID-19 and the most common lung disease caused by it, Acute Respiratory Distress Syndrome (ARDS), are accelerating their efforts to take their treatments into clinical settings.

“One of our first goals would be for existing StartX genetics companies to be able to ramp-up their current solutions for molecular testing of COVID-19 diagnostics and work with local and state officials and government agencies on deployment,” stated Dr. Michael Niaki, StartX Med COVID-19 Task Force Lead for the Diagnostics Subgroup.

Current StartX Med COVID-19 Task Force Participants include:

Prevention: DawnLight Technologies Luma HealthMon AmiTheranovaTueoQventus

Diagnostics: Avails MedicalEkoEnable BiosciencesInflammatixLucira HealthMagnetic Insight MendoNirmidas Biotech, Inc.ProbiusDxSandstone DiagnosticsSensio AirSentinel HealthcareSpire HealthSubtle MedicalQuantumcyte

Treatment: AugmedixBiozBright.mdChimera BioGEn1EGlobavir BioSciencesGuided ClarityInfiniGeneKangarooHealthOMNYOrcabioParzivalPotreroQventusSpot BiosystemsLine Up Health Wellsheet

“As the number of positive cases continue to soar in the outbreak of COVID-19, there is an imminent need for reducing barriers companies are experiencing with therapeutic medical breakthroughs needing to be deployed,” stated Joseph Huang, CEO of StartX. “We’ve always said that our community of industry leaders can achieve more as a group than as individuals and this is a prime example of how quickly StartX companies and the Stanford entrepreneurship ecosystem can mobilize and come together in times of crisis.”

In addition to partnering in outreach to government agencies and public health offices for immediate deployment of life-saving medical solutions, the coalition will offer investors a special COVID-19 Task Force version of StartX’s Online Investor Demo Day viewings to coordinate introductions between StartX Med companies tackling COVID-19 and VCs specifically interested in investing in this space. Both StartX’s General Investor Demo Day and COVID-19 specific viewings are slated to begin March 19, 2019.

Media Note: Leading Physician and Scientist Expert Sources Available for Comment

About StartX

StartX is a nonprofit organization advancing the development of Stanford’s top entrepreneurs through experiential education, access to thousands of VCs and investors, and a Who’s Who of industry leaders and serial entrepreneurs providing mentorship. The founder community consists of a diverse mix of 1500+ well-funded Growth-Stage Founders, tenured Stanford Professor Founders, and highly-successful Stanford Alumni Founders. Collectively, StartX companies have raised $8 billion in funding with a combined valuation of more than $25 billion to date. StartX’s Corporate Innovation program helps global corporations quickly test market-ready technology from Stanford alumni founders through structured co-creation and pilot programs. Ranked as a number one accelerator nationally by MIT’s Seed Accelerator Rankings Project, StartX venture funded companies have a 92% survival and acquisition rate in a wide range of industries from consumer Internet and retail products to enterprise software, biotechnology and medical devices.

StartX and StartX Med, the medical entrepreneurial vertical of StartX, includes accomplished founders ranging from undergraduates and masters students to post docs, professors and Stanford alumni being mentored by top Silicon Valley industry leaders. For medical tech founders homegrown at Stanford’s School of Medicine, having intimate access to domain experts and care environments has been fundamental to their success. StartX Med entrepreneurial scientists are changing the world with medical breakthroughs and successful life-saving research trials, including an average of more than six FDA approvals per year. Clinical partners of StartX Med companies encompass more than 250 hospitals, 30,000 care centers, 50,000 physicians and 65 million annual patient visits. StartX Med founders also have the opportunity to utilize 2,000 square feet of shared wet lab space at the StartX facility, located down the street from Stanford University. StartX continues to be a unique startup community compared to accelerators and incubators and does not take equity in companies for admittance into its programs. For information on the StartX Med COVID-19 Task Force or how you can help, please send inquiries to: [email protected]

Contacts

Laurie Peters, Communications Director
StartX
[email protected]
(818) 635-4101

March 4, 2020 – New Inflammatix Study in Nature Communications Outlines Breakthrough in Diagnosing Acute Infections by Reading the Immune System2020-03-04T08:41:42-08:00

Burlingame, Calif., March 4, 2020  —  Novel Machine Learning Host-Response-Based Approach Forms the Basis of Company’s Tests.  Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, announced findings from a new study published today in Nature Communications that demonstrate its ability to identify patients with bacterial versus viral infections using a data-driven approach that measures the immune system response. The molecular classifier used in the study forms the basis of Inflammatix’s HostDx rapid tests, which the company is developing to overcome traditional challenges of diagnosing acute infections and sepsis.

“When seeing a sick patient with a suspected infection in the emergency room, most physicians are forced to basically make an educated guess about whether the patient has a bacterial or viral infection, and then treat accordingly. Unfortunately, despite best efforts, this guessing game can have terrible outcomes for patients and for our health system” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix.

“For 20 years, researchers have been looking for a way to use transcriptomics – the study of the body’s gene expression – to classify patients with acute infections. To date, others’ attempts to apply machine learning to this problem have not held up when applied to diverse patient populations. Our new study is the first time that a locked, multi-gene signature has been validated in a blinded, independent clinical cohort. It represents a major technical breakthrough in translating our tests to the clinic.”

For the new publication, Inflammatix and Stanford scientists applied advanced machine learning to develop a 29-gene classifier (“BVN-1”) that can identify bacterial, viral or no infections across 1,069 blood samples from 18 prior studies of patients diagnosed with acute infections. The patients represented a wide range of geographic regions, clinical care setting and disease contexts.

The researchers then tested the locked classifier – i.e., without modification or retraining – on an independent cohort of 109 patients from Stanford University’s intensive care unit who underwent evaluation for acute infection and sepsis. They found that the test was highly accurate in diagnosing infections, especially among patients tested within 36 hours of hospital admission – a critical time for determining treatment. Among this subset, the test demonstrated an AUROC of 0.92 (95% CI; 0.83-0.99) for identifying patients with bacterial infections and 0.91 (95% CI; 0.82-0.98) for viral infections.

The molecular classifier also demonstrated higher accuracy than standard biomarkers – procalcitonin (PCT) and C-reactive protein (CRP) – that have been associated with acute infections and sepsis. Among the subset of patients with PCT and CRP results in the Stanford ICU cohort, the Inflammatix test had an AUROC of 0.87 (95% CI; 0.8-0.94) for bacterial infections, compared to 0.83 (95% CI; 0.75-0.92) for PCT and 0.70 (95% CI; 0.6-.081) for CRP. Neither PCT nor CRP could positively identify viral infections.

“To wit, 100% of the patients in this cohort were on antibiotics, but many did not have an underlying bacterial infection. Improved diagnostics would benefit patients and have a major impact on the healthcare system,” said Dr. Sweeney.

“Furthermore, our machine learning team has demonstrated the power of our computational platform in a highly heterogeneous and difficult field. We look forward to bringing the same computational tools to bear across multiple other infectious and inflammatory diseases.”

Antibiotic resistance and sepsis lead to more than 700,000[i] and 5 million[ii] respective deaths worldwide each year. Inflammatix’s HostDx Sepsis and HostDx Fever tests use proprietary machine learning algorithms that incorporate the expression of multiple immune genes (host response) to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. Inflammatix’s simple-to-use, sample-to-answer HostDx system is designed to produce results at or near the point of care in 30 minutes or less. The company plans to advance its HostDx tests through commercial launch in Europe and submission to the United States Food and Drug Administration in 2021.

In January 2020, Inflammatix announced it had received $32 million in Series C financing. Prior to that, in November 2019, the company announced a cost-sharing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx tests. The agreement is worth up to $72 million based on achieving certain milestones.*

Citation

Mayhew, MB et al. A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections. Nature Communications, 2020. https://doi.org/10.1038/s41467-020-14975-w

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

*This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413


[i] Interagency Coordination Group on Antimicrobial Resistance. No Time to Wait: Securing the Future from Drug-Resistant Infections; Report to the United Nations. April 2019.

[ii] Rudd KE, et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. Lancet 2020; 395:200-211.

January 10, 2020 – Inflammatix Announces $32 Million in Series C Funding2020-03-04T08:29:13-08:00

Burlingame, Calif., January 10, 2020  —  Financing will be used to advance HostDx™ tests for acute infections and sepsis to commercial launch in 2021.  Inflammatix, a pioneering molecular diagnostics company delivering precision medicine at the point of care, today announced a $32 million Series C financing. The funding round included participation from existing investors Khosla Ventures, Northpond Ventures and Think.Health Ventures, and new investors that include Grey Sky Venture Partners. The funds will be used to advance Inflammatix’s rapid HostDx™ tests through commercial launch in Europe and submission to the United States Food and Drug Administration in 2021.

“We are pleased to have the support of this strong group of healthcare investors who share our excitement about leveraging the immune response to build novel precision diagnostics for infectious and inflammatory disease. In particular, our first tests will help tackle antibiotic resistance and sepsis, two critical public health challenges, by reading the patient’s host-immune response to infection,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “With this financing in hand, we look forward to bringing our rapid HostDx tests into hospitals and clinics so that physicians can quickly get the right treatments to the right patients.”

The Series C funding follows an announcement in November 2019 that the company had signed a long-term cost-sharing contract to develop its tests for acute infections and sepsis with the Biomedical Advanced Research and Development Authority (BARDA) worth up $72 million based on achieving certain milestones.*

Antibiotic resistance and sepsis cause more than 700,000 and 5 million deaths worldwide each year, respectively. Traditional methods for diagnosing acute infections are too slow and are often inaccurate because they only look for pathogens in the bloodstream, despite most infections never entering the bloodstream. As a result, patients with suspected infection are often blindly treated with antibiotics – contributing to antibiotic resistance – or sepsis can be missed altogether.

Inflammatix’s HostDx Sepsis and HostDx Fever tests use proprietary machine learning algorithms that incorporate the expression of multiple immune genes (host response) to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. Inflammatix’s simple-to-use, sample-to-answer HostDx system is designed to produce results at or near the point of care in 30 minutes or less.

“Inflammatix’s team is advancing our knowledge of how to use the immune system and immune responses to improve the diagnosis of acute infections and sepsis,” said Mike Rubin, M.D., Ph.D., founder and chief executive officer of Northpond Ventures. “We believe their innovations in data science expertise and rapid multiplex test system have the power to transform care across a spectrum of medical conditions and diseases.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infection and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in under 30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, Grey Sky Venture Partners and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

*This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Nos. 75A50119C00034 and 75A50119C00044.

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

November 14, 2019 – Inflammatix Announces Funding from BARDA to Advance HostDx™ Tests2019-11-14T14:57:34-08:00

Burlingame, Calif., November 14, 2019  —  HostDx Fever Test Reads the Immune System to Rapidly Diagnose Acute Infections at Point of Care.  Inflammatix, a pioneering molecular diagnostics company, announced today an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx™ tests. Under the contract, Inflammatix will receive $6 million in the first phase of a cost-sharing contract worth up to $72 million based on achieving certain milestones.

The new contract will advance development and commercialization of Inflammatix’s simple sample-to-answer, point-of-care HostDx test system, which will produce results in under 30 minutes. The first phase of work will focus on the novel HostDx Fever test. The HostDx Fever test “reads” gene expression patterns in the immune system to quickly identify whether a suspected infection is bacterial or viral, enabling physicians to quickly and accurately determine whether to prescribe antibiotics. The HostDx Fever test will be run from a fingerstick blood sample and will be used primarily in primary care, urgent care and other outpatient clinical settings. Today, an estimated 30 percent of antibiotics are inappropriately prescribed to patients with infections because their infections are not obviously bacterial or viral in origin.

“We are thrilled to receive this funding from BARDA, which will enable us to advance our HostDx Fever test into the clinic where it will help physicians quickly diagnose infections so they can get the right treatments to the right patients. This ability is key to combatting antibiotic resistance, which is one of the most pressing public health challenges of our time,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “Through this public-private sector partnership, we will move precision medicine to the point of care, where it can have an immediate impact on patient outcomes.”

Current methods for diagnosing infections are too slow and often inaccurate, resulting in delayed or inappropriate treatment. Infections are often blindly – and incorrectly – treated with antibiotics, which contributes to antibiotic resistance. Each year at least 2 million Americans become infected with bacteria that are resistant to antibiotics and at least 23,000 die as a direct result.

The contract may optionally support two additional Inflammatix tests: HostDx Sepsis and HostDx FeverFlu. HostDx Sepsis is a blood-based test that will rapidly diagnose infections in patients in emergency department or other hospital settings and determine which patients are likely to have or develop sepsis. HostDx FeverFlu will be performed on nasal swab samples and will combine traditional influenza testing with host-response biomarkers.

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in 20-30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00034.

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

August 6, 2019 – Inflammatix Wins AACC’s Disruptive Technology Award For Its Rapid HostDx™ Tests2019-08-06T15:48:57-07:00

Burlingame, Calif., August 6, 2019  — Inflammatix, a molecular diagnostics company that is reimagining diagnostics, announced today that it has received the American Association for Clinical Chemistry’s (AACC) Disruptive Technology Award for its rapid HostDx™ tests, which read the immune system to improve diagnosis of acute infections and sepsis. The award was based on the company’s presentation  during the 71st AACC Annual Scientific Meeting, which is being held August 4-8 in Anaheim, Calif.

“We are extremely honored to receive this prestigious award, which recognizes the power of our proven technology to transform diagnosis of acute infections and sepsis,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “We believe our rapid HostDx tests will enable physicians to more quickly get the right treatments to the right patients, improving patient outcomes and ultimately reducing the global health burdens of antibiotic resistance and sepsis.”

Inflammatix’s first test, HostDx Sepsis, will use proprietary algorithms to read the immune system’s response to infection. The test measures the expression of multiple immune genes to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. In contrast, while traditional diagnostic approaches look for blood-based pathogens, most infections – and nearly half of sepsis cases – are negative for bloodstream pathogens. Inflammatix’s technology is proven in dozens of studies involving over 2,400 patients and published in leading peer-reviewed journals. The company is developing a proprietary cartridge-based system that will produce rapid results at or near the point of care in 30 minutes or less and plans to seek FDA clearance for the HostDx Sepsis test.

Each year in the United States alone, 20 million patients are assessed for acute infections and sepsis in emergency department and other hospital settings. Sepsis, a life-threatening condition in which the body’s immune system becomes dysregulated fighting an infection, kills more than 250,000 people in the United States each year and is estimated to cause or contribute to over five million deaths worldwide annually.

AACC’s Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high quality testing. Inflammatix was one of three finalists selected to present to a panel of expert judges during a special session of the AACC meeting. The company was selected based on its technology’s clinical validity, patient impact, market opportunity, business model, competitive analysis, intellectual property strength, regulatory plan, team strength and stage of development.

Inflammatix also received the Audience Choice award based on the audience’s votes for their favorite technology.

About Inflammatix

Inflammatix is a molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s initial focus is on acute infections and sepsis, where its HostDx™ tests combine proprietary biomarkers and advanced machine learning to help physicians quickly get the right treatments to the right patients. Each test will be developed to run on the company’s sample-to-answer isothermal instrument platform in 20-30 minutes, enabling the power of precision medicine at the point of care. The Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

May 16, 2019 – Inflammatix Named a Finalist for AACC’s Disruptive Technology Award for Its Rapid HostDx™ Tests2019-05-16T12:58:28-07:00

Burlingame, Calif., May 16, 2019  — Inflammatix announced today that it has been named a finalist for the American Association for Clinical Chemistry’s (AACC) Disruptive Technology Award  for its rapid HostDx™ tests, which read the immune system to improve diagnosis of acute infections and sepsis. Inflammatix is one of three finalists that will present its technology at the 71st AACC Annual Scientific Meeting in Anaheim, Calif., during a special session on August 5, 2019.

“We are honored to be selected as a finalist for this prestigious award,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “This recognition underscores the power of our approach of evaluating the body’s immune system to diagnose infections and sepsis faster and more accurately than current methods.”

Inflammatix’s first test, HostDx Sepsis, uses proprietary algorithms to diagnose the host response to infection. Specifically, it measures the expression of multiple immune genes to identify the presence of bacterial or viral infections and to determine if a patient has or is likely to develop sepsis. In contrast, traditional diagnostic approaches look for blood-based pathogens, but most infections – and nearly half of sepsis cases – are negative for bloodstream pathogens. Inflammatix is developing a proprietary cartridgebased point-of-need system that will produce rapid sample-to-answer results in 30 minutes or less and plans to seek FDA clearance for the HostDx Sepsis test.

Sepsis, a life-threatening condition in which the body’s immune system becomes dysregulated fighting an infection, kills more than 250,000 people in the United States each year and is estimated to cause or contribute to over five million deaths worldwide annually.

AACC’s Disruptive Technology Award recognizes innovative testing solutions that improve patient care through diagnostic performance or access to high quality testing.

About Inflammatix

Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections and sepsis, where its HostDx™ tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses the 70% of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Northpond Ventures, the Stanford-StartX Fund and Think.Health Ventures. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

October 4, 2018 – Inflammatix to Present New Data at IDWeek 2018 Demonstrating Ability to Perform HostDx™ Fever Test to Rapidly Distinguish Bacterial from Viral Infections Across Multiple Laboratory Platforms2018-10-16T16:49:43-07:00

Burlingame, Calif., October 4, 2018  — Inflammatix today announced that it will present findings from two studies demonstrating the ability of its HostDx™ Fever test to distinguish bacterial from viral infections on multiple rapid laboratory platforms that can deliver results in under 30 minutes. The new data will be presented at the Infectious Diseases Society of America (IDSA) IDWeek™ 2018 taking place October 3-7, 2018, in San Francisco.

The HostDx Fever test is designed to help physicians differentiate acute bacterial and viral infections quickly and accurately in outpatient and urgent care settings. It uses gene expression data and bioinformatics to read the immune system response, rather than look for specific pathogens. The new data at IDWeek 2018 will demonstrate the company’s successful translation of its core technology onto rapid isothermal and PCR laboratory platforms, which can enable rapid results at or near the point of care.

“Acute infections are among the most frequent diagnoses in outpatient care settings, but they are challenging to diagnose, and current testing methods are inaccurate or too slow. As a result, infections are often blindly – and incorrectly – treated with antibiotics,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “The HostDx Fever test is designed to help physicians quickly diagnose acute bacterial and viral infections in order to improve patient care, reduce healthcare costs and tackle the growing public health problem of antimicrobial resistance. The data we are presenting at IDWeek 2018 show that the genes comprising the HostDx Fever test can be accurately and rapidly measured across multiple rapid laboratory methods, potentially enabling broader access to the test.”

The following abstracts will be presented as posters at the IDWeek 2018 conference:

Title: Taqman multiplex PCR of a seven-gene host biomarker to discriminate bacterial from viral infections (Abstract #72231)
Presenter: Wensheng Nie, Ph.D., Inflammatix
Date/Time: Saturday, October 6, 12:30-1:45 p.m. Pacific Time
Session: Diagnostics: Biomarkers and Novel Approaches
Location: Moscone Convention Center, Hall C, Poster #2016

Title: An ultra-rapid host response assay to discriminate between bacterial and viral infections using quantitative isothermal gene expression analysis (Abstract #72198)
Presenter: David C. Rawling, Ph.D., Inflammatix
Date/Time: Saturday, October 6, 12:30-1:45 p.m. Pacific Time
Session: Diagnostics: Biomarkers and Novel Approaches
Location: Moscone Convention Center, Hall C, Poster #2021

About the HostDx Fever Test

The HostDx Fever test helps determine whether a suspected infection is likely bacterial or viral. The test uses novel, validated technology to measure the expression levels of select host immune genes in blood samples and then applies proprietary algorithms to produce clinically actionable and timely results. The HostDx Fever test’s technology has been validated in 24 cohorts of over 1,000 patients with suspected infection. The test has demonstrated a high sensitivity for bacterial infection (94 percent) and high negative predictive value (97 percent) and its performance was consistent regardless of the infection subtype, clinical setting and time of the year.

About Inflammatix

Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections, and sepsis, where its HostDx Sepsis and HostDx Fever tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses the 70 percent of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Think.Health, Stanford-StartX Fund and grants from the federal government. For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

April 10, 2018 – Inflammatix Named a Finalist in Fast Company’s 2018 World Changing Ideas Awards for Its Novel HostDx Tests2018-04-10T09:55:32-07:00

Burlingame, Calif., April 10, 2018  — Inflammatix announced today that it has been named a finalist in Fast Company’s 2018 World Changing Ideas Awards for its novel HostDx™ tests, which read the immune system to tackle the global health problems of antibiotic resistance and sepsis. The annual award honors businesses, policies, projects and concepts that offer innovative solutions to the issues facing humanity. Finalists and winners will be highlighted in the May issue of the print magazine, which hits newsstands on April 17.

“We are deeply honored to receive this recognition from Fast Company, which is recognized worldwide as an authority on innovation,” said Tim Sweeney, M.D., Ph.D., co-founder and chief executive officer of Inflammatix. “This recognition emphasizes our commitment to harnessing the power of the immune system to improve patient care and resolve major clinical and public health challenges.”

Inflammatix is working with clinical diagnostics instrument partners to commercialize its HostDx tests, which will initially target acute bacterial and viral infections and sepsis. Rather than look for specific pathogens or biomarkers of disease, which lack accuracy and speed, the HostDx tests measure the genomic “fingerprint” of the host response to disease and apply proprietary machine learning algorithms to accurately identify whether an infection is bacterial or viral – and thus whether antibiotics are required – and to determine if the patient is likely to have or develop sepsis.

About the World Changing Ideas Awards

World Changing Ideas is one ofFast Company’s major annual awards programs and is focused on social good, seeking to elevate finished products and brave concepts that make the world better. A panel of judges from across sectors chooses winners and finalists based on feasibility and the potential for impact. With a goal of awarding ingenuity and fostering innovation, Fast Companydraws attention to ideas with great potential and helps them expand their reach to inspire more people to start work on solving the problems that affect us all.

Now in its second year, the World Changing Ideas Awards showcases 12 winners and more than 200 finalists. A panel of eminent judges selected winners from a pool of more than 1,300 entries in 12 categories, with entries from across the globe.

About Inflammatix

Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections, and sepsis, where its HostDx™ tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance.While current tests diagnose infections by “finding the bug” – an approach that misses the 70% of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Stanford-StartX Fund and grants from the federal government. For more information, please visit www.inflammatix.comand follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

February 15, 2018 – New Study Published in Nature Communications Suggests Sepsis Can Be Detected By Measuring the Immune System2018-02-15T12:09:09-08:00

Bioinformatics Approach Forms the Basis of Inflammatix’s HostDx™ Sepsis Test

Burlingame, Calif., February 15, 2018 — Inflammatix announced findings from a new study published today in Nature Communications that suggest that diagnosing and determining who will likely develop sepsis can be improved with a data-driven approach that measures the immune system response to severe infection. A gene expression model used in the new study is a core component of HostDx™ Sepsis, a rapid molecular test that Inflammatix is developing to improve sepsis diagnosis. Sepsis, a dysregulated immune system response to infection, kills more than 250,000 Americans and costs the healthcare system more than $27 billion annually in the United States.

“Current tools for sepsis identification and triage are imprecise, which often results in patients being overtreated or undertreated and wastes significant healthcare resources. The findings in this new study suggest that measuring immune dysregulation could indicate infection severity and significantly improve sepsis diagnosis,” said Tim Sweeney, M.D., lead author of the new paper, and cofounder and chief executive officer of Inflammatix. “The technology used in this study forms the basis of our HostDx Sepsis test, which we plan to bring into hospitals and urgent care settings as a rapid test to help reduce the global burden of sepsis.”

The new study evaluated gene-based models designed to accurately predict 30-day mortality in patients with sepsis at the time of enrollment. The models were developed and evaluated on over 20 cohorts from clinical studies involving a wide range of populations and settings. Inflammatix holds exclusive license to a pending patent from Stanford University for the institution’s gene expression model from the new study.

The Stanford gene set licensed by Inflammatix, when combined with clinical severity scores (the current standard of care), demonstrated a substantial increase in prognostic power for 30-day mortality (i.e., an AUC increase of 9.8 percent, from 77 percent to 87 percent). This would translate to an ability to rule out approximately 20 percent more sepsis cases, compared to clinical severity scores alone. Such findings suggest this approach could help save substantial resources by avoiding unnecessary care.

“This new research, combined with previously published data, demonstrate the HostDx Sepsis test’s ability to identify the presence of bacterial and/or viral infection and determine the likelihood of a patient having or developing sepsis. We believe this powerful combination will strongly drive the economic value of HostDx Sepsis, a point we look forward to validating in interventional trials,” said Dr. Sweeney.

About the HostDx Sepsis Test

The HostDx Sepsis test helps diagnose sepsis by detecting the presence of a bacterial and/or viral infection and determining its severity. The test uses novel, validated technology to measure the expression levels of numerous host immune genes in blood samples and then applies proprietary algorithms to produce clinically actionable and timely results. The HostDx Sepsis test’s technology has been validated in 20 cohorts of over 1,000 patients, representing diverse populations and settings. The test has demonstrated a high sensitivity for organ dysfunction associated with sepsis (95 percent) and high negative predictive value (>98 percent).

About Inflammatix

Inflammatix is a molecular diagnostics company that is developing rapid tests that read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections, and sepsis, where its HostDx™ tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses the 70% of infections that never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in over 20 independent cohorts involving over 1,000 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Stanford-StartX Fund and the U.S. government’s Defense Advanced Research Projects Agency (DARPA). For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contacts

For Inflammatix:
Tracy Morris
[email protected]
650-380-4413

December 19, 2017 – Inflammatix Announces Appointment of Oliver Liesenfeld, M.D., as Chief Medical Officer2018-10-16T16:53:44-07:00

BURLINGAME, Calif.Dec. 19, 2017 /PRNewswire/ — Inflammatix, a molecular diagnostics company that is developing rapid tests that read the immune system to improve disease diagnosis, today announced that Oliver Liesenfeld, M.D., has been appointed chief medical officer. Dr. Liesenfeld, a veteran of the diagnostics industry, comes to the company from Roche Molecular Diagnostics, where he served as chief medical officer since 2012.

Dr. Liesenfeld will oversee the clinical studies and regulatory approvals needed to commercialize Inflammatix’s HostDx™ tests, which will initially target acute infections and sepsis, respectively. These tests use the company’s novel, validated, bioinformatics-based approach of reading the genomic “fingerprint” of the host response to disease to quickly determine if a patient has a bacterial and/or viral infection – and thus, whether they need antibiotics – and to measure the severity of disease to determine if the patient is likely to have or develop sepsis.

“We are delighted to have an individual of Dr. Liesenfeld’s experience and stature join our team as we transform infectious disease diagnosis and resolve the pressing public health challenges of antibiotic resistance and sepsis,” said Tim Sweeney, M.D., Ph.D., cofounder and chief executive officer of Inflammatix. “With his extensive background in diagnostics, particularly in infectious diseases, and his broad regulatory experience, he will be key to helping us achieve our ambitious goals.”

Dr. Liesenfeld has over 25 years of industry and academic experience in the diagnostics field, with a focus on molecular diagnostics and infectious diseases. As chief medical officer at Roche Molecular Diagnostics, he built a state-of-the-art medical department and led the company’s clinical science, medical affairs, clinical operations and biometrics functions. His team designed and executed numerous clinical trials to support regulatory approvals and commercialization of the company’s broad product portfolio, including the LightCycler® SeptiFast test for use in sepsis diagnosis. Prior to Roche, Dr. Liesenfeld served as associate professor of Medical Microbiology and Infection Immunology at the Charite Medical School in Berlin, Germany, where his research focused on the immune response to infections. He holds an M.D. and a doctoral (Dr. med) degree from the Free University of Berlin, Germany and completed his residency in medical microbiology and infection epidemiology at the Charite Medical School, Berlin. He also completed a postdoctoral fellowship in the Division of Infectious Diseases and Geographic Medicine at Stanford University. Dr. Liesenfeld has authored more than 160 articles in peer-reviewed journals and more than 30 book chapters.

“I believe that a data-driven, bioinformatics approach that measures patients’ immune response represents the future of improved diagnosis for numerous diseases and conditions,” said Dr. Liesenfeld. “I am excited to join Inflammatix and advance their groundbreaking work in acute infections and sepsis, where current testing methods are inaccurate or too slow. I look forward to bringing their HostDx tests into the clinic where they can support the improved management of patients, helping physicians quickly get the right treatments to the right patients.”

About Inflammatix

Inflammatix is a molecular diagnostics company that is developing rapid tests that use bioinformatics and machine learning to read the immune system, enabling improved patient care and reducing major public health burdens. The company’s initial focus is on acute bacterial and viral infections, and sepsis, where its HostDx™ tests will allow physicians to quickly get the right treatments to the right patients, reducing morbidity and mortality, health system costs, and antibiotic resistance. While current tests diagnose infections by “finding the bug” – an approach that misses many infections because they never enter the bloodstream – Inflammatix evaluates the body’s immune system response to provide more accurate and faster diagnosis. Its scientific approach has been validated in 38 cohorts involving over 2,400 patients and published in leading medical journals. The privately held, Burlingame, Calif.-based company is funded by Khosla Ventures, Stanford-StartX Fund and the U.S. government’s Defense Advanced Research Projects Agency (DARPA). For more information, please visit www.inflammatix.com and follow the company on Twitter (@Inflammatix_Inc).

Media Contact:
Tracy Morris
[email protected]
650-380-4413

Inflammatix in the News

360 Dx Logo

Rapid Tests Continue Push Into Sepsis Market in 2023 as Competition Heats Up

January 2, 2024

bioworld

Inflammatix sepsis test scores FDA breakthrough device designation

November 28, 2023

360 Dx Logo

Inflammatix Aims for 2024 Launch of 30-Minute Sepsis and Acute Infection Test

November 28, 2023

The Wall Street Journal

Your medical devices are getting smarter. Can the FDA keep them safe?

October 9, 2023

Point-of-care testing for infectious diseases in emergency settings

January 18, 2023

The Atlantic

Do Your Genes Know What’s Making You Sick?

January 6, 2022

frontiers in medicine

Artificial Intelligence for Clinical Decision Support in Sepsis

May 13, 2021

mddi Logo

Inflammatix Checks off All the Right Boxes with Investors

March 19, 2021

fierce biotech Logo

Inflammatix nets $102M to advance its immune system tests for infectious diseases

March 16, 2021

San Francisco Business Times Logo

Infection-detection system from Peninsula company scores $102M, aims to hit market this year

March 16, 2021

aacc Logo

A Bright Future Ahead for Novel Markers of Infection

December 15, 2020

360 Dx Logo

Inflammatix Awarded $7.4M in Additional BARDA Funding for POC System, Acute Infection Test

October 29, 2020

360 Dx Logo

Inflammatix Moving Into Coronavirus Test Market With Gene Expression Host Response Platform

October 8, 2020

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Machine Learning-Based Rapid Diagnostic Reads Immune System to Predict COVID-19 Severity Risk

September 30, 2020

Three Predictions For Healthcare Platforms

September 8, 2020

Medical Design & Outsourcing Logo

20 medical device startups you need to know

June 26, 2020

medtech innovator

MedTech Innovator Announces Top 50 Medtech Startups Selected for Annual Showcase and Accelerator

June 22, 2020

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The Life Science Sector Shifts Its Focus Quickly to Respond to the Coronavirus

April 22, 2020

aacc Logo

The Battle for a Better Sepsis Test

April 1, 2020

Silicon Valley Business Journal

Stanford alumni founders tackle COVID-19 with StartX task force

March 19, 2020

Bio Space Logo

Leading Stanford Alumni Scientists and Physicians Launch StartX Med COVID-19 Task Force

March 18, 2020

Inflammatix named to Fierce 15 MedTech list

March 9, 2020

Diagnostic World Logo

New Technologies Can Step Up Fight Against Antimicrobial Resistance and Sepsis

January 10, 2020

Fierce Biotech logo

Inflammatix raises $32M, plus a BARDA contract, for its point-of-care infection diagnostics

January 10, 2020

genome web Logo

Inflammatix Raises $32M in Series C Financing

January 10, 2020

ASPR Logo

The skyrocketing need for speed

January 8, 2020

Archived News

12.04.2019 Genetic platform takes the guesswork out of catching infections

11.18.2019 BARDA awards contract to Inflammatix for innovative diagnostic test systems

11.15.2019 BARDA backs Inflammatix test to improve antibiotic use

11.15.2019 Inflammatix Nabs $6M from BARDA to Develop POC Acute Infection Diagnostic

11.14.2019 Inflammatix scores BARDA contract for infection tests

11.14.2019 How $6 million could help a small Peninsula company spot deadly infections

11.14.2019 Inflammatix Inks BARDA Contract for up to $72M

09.20.2019 AACC panel votes Inflammatix technology most disruptive

08.16.2019 Inflammatix Preps Immune-Response Sepsis Dx for FDA Clinical Trial, Lays Out Future Test Plans

08.06.2019 AACC: Inflammatix sepsis test wins Disruptive Technology contest

02.13.2019 Novel Technologies, Machine Learning Are The Keys To Improving Acute Infection Diagnostics

10.28.2018 Immune Profiling: A New Way to Diagnose Infections

04.17.2018 The quest to solve sepsis

04.09.2018 Inflammatix: a 2018 World Changing Ideas Award Finalist!

03.15.2018 Read Immune Responses to See Infections

03.12.2018 Inflammatix announced findings from a new study published in Nature Communications

03.09.2018 Spotlight: Interrogating the Immune System for Diagnosing Infection

02.22.2018 Informing Infection. Measuring gene expression patterns to diagnose and inform treatment decisions

02.21.2018 Sepsis severity may be discernible, new study suggests

02.15.2018 Study: Inflammatix’ HostDx sepsis test can aid in diagnosis, risk of sepsis

01.17.2018 Inflammatix Immune Response Tests could enable antibiotic decisions in one hour

12.19.2017 How a young Peninsula company snagged a onetime Roche exec to battle sepsis

09.28.2017 Diagnosis: Frontiers in blood testing

06.12.2017 Wanted: More Data, the Dirtier the Better. Embracing messy data as a way to capture the messiness of disease

05.24.2017  Stanford Spinout Inflammatix Developing Sepsis Diagnostic Based on Host Immune Response

10.24.2016 Researchers at the Stanford School of Medicine Develop Cutting-Edge Test to Identify Whether an Infection is Bacterial or Viral

07.07.2016 A Blood Test to Determine when Antibiotics are Warranted

07.06.2016 For someone with an infectious disease, the ability to distinguish between a viral and a bacterial cause would be game-changing

07.06.2016 Do You Really Need Antibiotics? This Test Can Tell.

07.06.2016 Simple blood test distinguishes between viral, bacterial infections

07.28.2015 Interview with Tim Sweeney, MD, PhD, Co-Founder of Inflammatix (begins @ 19:40)

Media Contact

Jonathan Romanowsky
Chief Business Officer
[email protected]
650.219.2141

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