Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test

First and only molecular blood test that can both identify bacterial and viral infections and assess need for critical care

Precision medicine approach aims to transform emergency triage standard of care

TriVerity expected to enable timely and confident decision-making for emergency departments

SUNNYVALE, Calif., Jan. 21, 2025 /PRNewswire/ -- 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 "The fundamental problem with existing tests is an outdated focus on labeling patients as 'septic or not.'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.

SOURCE Inflammatix