The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) purchases TriVerity Test System to evaluate for use in the field

Inflammatix receives an initial $1.2 million to cover the first phase of system evaluation, with future phase options worth up to $20.8 million

 Sunnyvale, Calif., March 25, 2025 — Inflammatix, a pioneering molecular diagnostics company, today announced the shipment of TriVerity™ cartridges and Myrna™ instruments to the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to facilitate the differentiation of bacterial infections, viral infections, and non-infectious illness. In the first phase of its agreement with Inflammatix, the JPEO-CBRND, which manages the acquisition, fielding and sustainment of chemical, biological, radiological, and nuclear (CBRN) defense capabilities to the joint force, will assess the viability of TriVerity cartridges and Myrna™ instruments for field use. The initial shipment, for which Inflammatix is to receive more than $1.2 million, is part of a JPEO-CBRND contract worth up to $20.8 million if all options are exercised.

TriVerity, Inflammatix’s flagship product, is a rapid blood test that measures the expression levels of 29 genes involved in the immune response associated with acute infection status and illness severity. The device, which was cleared for clinical use by the U.S. Food and Drug Administration (FDA) on January 10, 2025, is designed to facilitate management of patients presenting with suspected acute infection or sepsis. As part of the first phase of the contract, the JPEO-CBRND will conduct cybersecurity analyses of TriVerity and evaluate the system’s suitability in a deployed military setting where personnel may be confronted with biothreat and endemic infectious diseases. The remainder of the contract grants the JPEO-CBRND the option to ruggedize and/or improve the Myrna instrument and enhance the test system for use in a field-forward setting.

“We are pleased that the JPEO-CBRND has chosen to evaluate our TriVerity Test System, including TriVerity cartridges and the Myrna instrument, for military use,” said Dr. Timothy Sweeney, CEO and co-founder of Inflammatix. “TriVerity’s ability to rapidly rule in and rule out bacterial infection, viral infection and illness severity has the potential to streamline triage for our Armed Forces in forward
environments. We are confident that this robust test system, which we have built for routine clinical use, can be modified and optimized for use in military settings.”

The JPEO-CBRND contract comes at a time of increasing risk of acute infection and sepsis in the U.S. military. Data suggest that soldiers in combat zones are at elevated risk of respiratory infections, with an incidence nearly three times as great as that in the adult civilian population; more than 40% of soldiers’ respiratory illnesses are attributed to unknown causative agents. 1 In an analysis of sepsis hospitalization data of active military personnel from January 1, 2011, to December 31, 2020, researchers reported an
overall incidence of 39.8 hospitalizations per 100,000 person-years. The annual incidence increased 64% from 2011 through 2019, then dropped in 2020, during the COVID-19 pandemic. 2 These trends highlight the need for a portable, well-built diagnostic test that can rapidly and reliably detect the presence and assess the severity of infection under battlefield conditions.

Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States government and reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising
or product endorsement purposes.

About the TriVerity™ Test System
The TriVerity™ Test System (“TriVerity”), Inflammatix’s flagship in vitro diagnostic (IVD) test, includes the TriVerity cartridge and the Myrna™ instrument. TriVerity incorporates a panel of 29 patient messenger RNAs (mRNAs) to rapidly “read” the body’s immune response to infection using machine learning-derived algorithms. TriVerity shows the likelihood of a bacterial infection, a viral infection, and illness severity in adult patients with suspected acute infection or sepsis that present to emergency
departments. TriVerity empowers physicians to confidently make care decisions, which could influence the selection of antimicrobial therapy, focused workups with judicious laboratory and imaging orders, and patient admission or discharge disposition.

About Inflammatix

Inflammatix, Inc., based in Sunnyvale, California, USA, is revolutionizing molecular diagnostics with machine-learning-powered technology to rapidly read a patient’s immune response. Our innovative diagnostics aim to improve patient care and tackle significant public health challenges. Designed for our advanced sample-to-answer isothermal instrument platform, our tests bring the power of precision medicine to the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital, Iberis Capital, and Vesalius BioCapital, 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; Administration for Strategic Preparedness and Response; and the Biomedical Advanced Research and Development Authority, under contract numbers 75A50119C00034, 75A50119C00044, and 75A50122C00069.

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

References
1. Korzeniewski K, Nitsch-Osuch A, Konior M, Lass A. Respiratory tract infections in the military environment. Respir Physiol Neurobiol. 2014;209:76-80.
2. Snitchler CL, Patel DM, Stahlman SL, Chauhan AV, Wells NY, Mcquistan AA. Sepsis hospitalizations among active component service members, U.S. Armed Forces, 2011-2020. MSMR. 2021;28(11):2-8. 

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

Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.  

“Despite billions of dollars’ worth of innovation and decades of work, sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system,” said Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix. “The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’ But sepsis is a syndrome, not a disease, and its definition keeps changing. We therefore designed TriVerity to look at its clinically actionable core elements: (1) does this patient have an infection, and (2) how sick are they likely to become?” 

Dr. Sweeney added, “When troponin monitoring came into mainstream practice, it transformed the syndrome of ‘chest pain,’ and outcomes for heart attacks improved dramatically. We think that syndromic acute infections are ready for a similar revolution in care, led by TriVerity.”

TriVerity is a rapid blood test that measures the expression levels of 29 genes associated with the host immune response to infection. The test uses validated algorithms developed applying artificial intelligence (AI)/machine learning to interpret the host response information into three scores that indicate the likelihood of (1) bacterial infection, (2) viral infection, and (3) severe illness (as defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days).

TriVerity is expected to ease the burden faced by hospital systems, which are plagued by emergency department (ED) overcrowding, and, for those patients admitted, with lengths of stay (LOS) commonly measured not in hours but in days or even weeks.¹ A large part of the problem is that for every patient identified with sepsis, typically 20 patients must be screened or tested.² Faster, more accurate triage of this patient segment may dramatically decrease resource strain, reduce unnecessary hospital admissions and LOS, and free up clinicians to focus on patients who truly need critical interventions. 

That is the gap TriVerity aims to close: by providing a precise measure of infection likelihood and risk stratification (instead of defaulting to a binary “sepsis” label), it helps EDs manage not just patients with sepsis, but also those with common acute infection presentations such as suspected pneumonia, cellulitis, or other infections. The long-term goal is to improve outcomes, survival rates, and healthcare utilization for a broad group of patients.

“FDA clearance of TriVerity comes at an opportune time for today’s overburdened emergency physicians, who now have a precise and reliable tool to facilitate the diagnosis and proper management of acute infections or sepsis,” said John W. Hafner, MD, emergency medicine physician at OSF HealthCare and program director, research director, and clinical professor of Emergency Medicine at the University of Illinois College of Medicine in Peoria. “In addition to identifying patients whose severe infections might otherwise have been missed, TriVerity can help quickly triage patients in the ‘grey zone,’ whose signs and symptoms are ambiguous and hard to diagnose.”

The FDA cleared TriVerity based on results from the SEPSIS-SHIELD study (NCT04094818), in which TriVerity yielded diagnostic and prognostic results with a high degree of accuracy in 1,222 enrolled patients across 22 sites, regardless of patients’ immune status or race. The FDA previously granted Breakthrough Device Designation to TriVerity in November 2023. FDA clearance of TriVerity is particularly notable, with only about 10% of designated Breakthrough Devices receiving marketing clearance.³

Hal Paz of Khosla Ventures, a lead investor in Inflammatix, commented, “As a former CEO of multiple large-scale health systems, I’ve seen how slow or inaccurate sepsis diagnosis harms patient care, drives up costs, and contributes to clinician burnout. TriVerity transforms that equation by reducing diagnostic uncertainty, streamlining care, lowering costs, and most importantly improving patient outcomes.”

“TriVerity is a first step towards accurate molecular characterization of acute illnesses,” noted Inflammatix Co-founder and Chief Scientist Purvesh Khatri, PhD, who is also Professor of Medicine at Stanford University. “Its unprecedented accuracy is the result of over a decade of rigorous state-of-the-art data science. We were able to integrate thousands of patient profiles into a set of robust classifiers and were thrilled that the accuracy was exactly in line with our expectations. Our combination of rapid, high-multiplex test results with data-driven insights will usher in the era of precision medicine for critical illnesses in which the immune host response is the determining factor in individualizing care for every patient walking into the emergency department.” 

About the TriVerity™ Test System

The TriVerity™ Test System (“TriVerity”), Inflammatix’s flagship in vitro diagnostic (IVD) test, includes the TriVerity cartridge and the Myrna™ instrument. TriVerity incorporates a panel of 29 patient messenger RNAs (mRNAs) to rapidly “read” the body’s immune response to infection using machine-learning-derived algorithms. TriVerity shows the likelihood of a bacterial infection, a viral infection, and illness severity in adult patients with suspected acute infection or sepsis that present to emergency departments. TriVerity empowers physicians to confidently make care decisions, which could influence the selection of antimicrobial therapy, focused workups with judicious laboratory and imaging orders, and patient admission or discharge disposition.

TriVerity is based on research done at Stanford University by co-founders Tim Sweeney and Purvesh Khatri, including intellectual property exclusively licensed from Stanford University.

About Inflammatix

Inflammatix, Inc., based in Sunnyvale, California, USA, is revolutionizing molecular diagnostics with machine-learning-powered technology to rapidly read a patient’s immune response. Our innovative diagnostics aim to improve patient care and tackle significant public health challenges. Designed for our advanced sample-to-answer isothermal instrument platform, our tests bring the power of precision medicine to the point of care. The company’s funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital Partners, Iberis Capital, and Vesalius BioCapital, 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; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract numbers 75A50119C00034, 75A50119C00044, and 75A50122C00069.

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

References

1. American College of Emergency Physicians. Emergency Department Boarding Crisis Sign-on Letter, November 7, 2022. https://www.acep.org/siteassets/new-pdfs/advocacy/emergency-department-boarding-crisis-sign-on-letter-11.07.22.pdf.
2. Wang HE, Jones AR, Donnelly JP. Revised National Estimates of Emergency Department Visits for Sepsis in the United States. Crit Care Med. 2017;45(9):1443-1449. doi: 10.1097/CCM.0000000000002538.
3. U.S. Food and Drug Administration. Breakthrough Devices Program, November 7, 2024.  https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#:~:text=Graph%202:%20Number%20of%20Granted,ABBOTT%20MEDICAL.  

Media Contact 

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

Inflammatix receives FDA clearance for its TriVerity™ Test, the first and only molecular blood test that can both identify bacterial and viral infections and assess need for critical care, expected to enable timely and confident decision-making for emergency departments.