Jan. 21, 2025—Inflammatix announced that the FDA has granted marketing authorization for the TriVerity test system, a molecular test for patients with suspected acute infection or sepsis. TriVerity incorporates a panel of 29 patient messenger RNAs to rapidly read the body’s immune response to infection using machine-learning–derived algorithms. The test shows the likelihood of a bacterial infection, viral infection, and illness severity in adult patients with suspected acute infection or sepsis who present to emergency departments.
The FDA cleared TriVerity based on results from the Sepsis-Shield study 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 granted breakthrough device designation to TriVerity in November 2023. The system includes the TriVerity cartridge and Myrna instrument.