FDA

FDA clears first in-class test for rapid sepsis diagnosis

January 24, 2025

Inflammatix received FDA clearance for its TriVerity Test System, a first-in-class molecular test designed to rapidly diagnose bacterial and viral infections and assess illness severity in patients with suspected acute infections or sepsis. FDA's decision was based on the SEPSIS-SHIELD study, which demonstrated high diagnostic and prognostic accuracy in 1,222 patients across 22 sites, regardless of immune status or race.

TriVerity uses AI and machine learning to measure the expression levels of 29 genes, interpreting host response data into three scores: likelihood of bacterial infection, viral infection, and severe illness.

According to a manufacturer press release, this approach allows for precise infection likelihood and risk stratification, moving beyond the traditional binary "sepsis" label and significantly improve emergency department triage.

Sources:

U.S. Food and Drug Administration. (2025, January 10). Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241676.pdf

(2025, January 21). Inflammatix. Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test. [Press release]. https://inflammatix.com/inflammatix-receives-fda-clearance-for-first-in-class-triverity-test/