Apr 29, 2020
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
Apr 16, 2020
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
Mar 18, 2020
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 Health – Mon Ami – Theranova – Tueo – Qventus
Diagnostics: Avails Medical – Eko – Enable Biosciences – Inflammatix – Lucira Health – Magnetic Insight Mendo – Nirmidas Biotech, Inc. – ProbiusDx – Sandstone Diagnostics – Sensio Air – Sentinel Healthcare – Spire Health – Subtle Medical – Quantumcyte
Treatment: Augmedix – Bioz – Bright.md – Chimera Bio – GEn1E – Globavir BioSciences – Guided Clarity – InfiniGene –KangarooHealth – OMNY – Orcabio – Parzival – Potrero – Qventus – Spot Biosystems – Line 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
Mar 4, 2020
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.
Jan 10, 2020
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
