Nov 28, 2023
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]
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.
Nov 15, 2023
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]
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.
Sep 13, 2023
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.
Jul 10, 2023
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.
Jun 15, 2022
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
Nov 30, 2021
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
