Company Spotlight: Inflammatix TriVerity - Reading the Immune System's RNA to Predict Sepsis

We dive into the FDA 510(k) summary for TriVerity by Inflammatix, a test that uses host-response mRNA to evaluate emergency department patients with suspected sepsis. Listeners will learn how it differentiates bacterial from viral infections and predicts the need for life support within seven days, all while exploring the real clinical data behind its clearance.

Key points

• The TriVerity test measures the expression of 29 host response genes and 3 housekeeping genes from whole blood using a technique called RT-LAMP.
• It outputs three distinct scores, each falling into one of five interpretation bands, to predict the likelihood of bacterial infection, viral infection, and severe illness.
• In a clinical study of 1,222 emergency department patients, the test achieved an area under the curve of 0.83 for bacterial infections and 0.91 for viral infections when using consensus clinical adjudication.
• For illness severity, it demonstrated an ability to predict the 7-day need for mechanical ventilation, vasopressors, or renal replacement therapy with an area under the curve of 0.78.
• When compared to the standard biomarker procalcitonin, TriVerity maintained consistent accuracy across different racial groups, whereas procalcitonin's accuracy varied widely.

Source: FDA 510(k) summary K241676: TriVerity (Inflammatix) - U.S. Food and Drug Administration, 2025

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Inflammatix (inflammatix.com) · Product: TriVerity · FDA 510(k) K241676

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-inflammatix-triverity-reading-the-immune-system-s-rn-7a51d5