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

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 “The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’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.”

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