The TriVerity Test System, claimed to be the first and only molecular blood test that can both identify bacterial and viral infections and assess need for critical care, has been granted marketing authorisation by the U.S. Food and Drug Administration (FDA).
TriVerity is 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 "The fundamental problem with existing tests is an outdated focus on labelling patients as 'septic or not.'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?"
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. 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.
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
TriVerity, which is 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 is based on research done at Stanford University by co-founders Tim Sweeney and Purvesh Khatri, including intellectual property exclusively licensed from Stanford University.
For more information, please visit www.inflammatix.com.