FDA clears TriVerity test to identify and assess acute sepsis and other infections

Credit: Inflammatix

Inflammatix announced Tuesday the comapny has received U.S. Food and Drug Administration (FDA) marketing authorization for TriVerity, a molecular test designed to identify bacterial and viral infections while assessing illness severity in patients with suspected acute infection or sepsis.

TriVerity is the first test of its kind to offer both rapid infection scoring and an all-cause illness severity risk evaluation, according to a company news release.

The diagnostic tool measures the expression levels of 29 genes associated with the immune response to infection. TriVerity then uses machine learning to generate three scores indicating the likelihood of bacterial infection, viral infection and severe illness. The test is intended to help emergency departments manage overcrowding by providing timely information on patients who might require critical care.

"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 health care system," said Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, in the news release. "The fundamental problem with existing tests is an outdated focus on labeling patients as 'septic or not.'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?"

FDA clearance was supported by data from the SEPSIS-SHIELD study, which enrolled 1,222 patients across 22 sites. Investigators reported TriVerity demonstrated diagnostic and prognostic accuracy regardless of patients’ immune status or race. The test previously received FDA Breakthrough Device Designation in November 2023, and only about 10% of devices with that designation advance to marketing clearance, according to the company.

"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 the news release. "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."

TriVerity combines a single-use test cartridge and the Myrna instrument to deliver results at the point of care. According to Inflammatix, the technology could inform decisions related to antimicrobial therapy, reduce unnecessary hospital admissions and guide patient disposition.

Inflammatix, based in Sunnyvale, Calif., is focused on host response diagnostics that use machine-learning-powered technology to interpret the body’s immune response. The company is backed by several investors, including Khosla Ventures, Northpond Ventures and the Stanford-StartX Fund.