FDA Approves TriVerity Test that Diagnoses Infections and Sepsis Faster

The FDA recently granted marketing authorization for the TriVerity Test System — a new molecular diagnostic test developed by Inflammatix.

This first-of-its-kind test provides a comprehensive assessment of patients with suspected acute infections or sepsis by measuring the body's immune response.

The TriVerity test offers clinicians a faster evaluation of infection type and severity, according to a news release.

Sepsis — a life-threatening condition caused by the body's response to infection — remains a significant challenge in healthcare.

According to the Mayo Clinc, as sepsis worsens, vital organs, such as the brain, heart and kidneys, don't get as much blood as they should.

Most can recover from mild sepsis, but the mortality rate for septic shock is about 30% to 40%.

Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, said billions of dollars and decades of work have been invested in sepsis care.

“Sepsis mortality remains frustratingly high, and sepsis remains the most expensive diagnosis to the healthcare system,” Sweeney added.

One of the key issues with existing diagnostic methods is the outdated focus on labeling patients as “septic or not,” despite the complex and evolving nature of sepsis, he said.

To address this gap, TriVerity focuses on whether the patient has an infection and how severely ill they are likely to become.

The TriVerity test measures the expression levels of 29 genes associated with the immune response to infection.

It also uses artificial intelligence and machine learning to create three critical scores: how likely it is that the patient has a bacterial infection, how likely it is they have a viral infection and the risk of developing a severe illness that might need treatments such as a breathing machine or strong medications within the next week.

These insights give a detailed outlook of a patient’s condition, enabling healthcare providers to make timely decisions.

Emergency departments across the country face many challenges, including overcrowding and lengthy hospital stays. TriVerity aims to alleviate this burden by improving the triage process, the release said.

Currently, assessing if a patient has sepsis usually results in testing or examining up to 20 people for every confirmed case.

This process can take up a significant amount of resources and can delay critical care.

By giving clear scores on the chances of infection and how serious it might be, the TriVerity test can help emergency departments handle not just sepsis cases but also other infections such as pneumonia or cellulitis more effectively.

John W. Hafner, MD, an emergency medicine physician at OSF HealthCare and clinical professor of Emergency Medicine at the University of Illinois College of Medicine, highlighted how the test can be particularly beneficial for patients in the “grey zone” by providing clarity and reducing diagnostic uncertainty.

The grey zone refers to those with ambiguous or hard-to-diagnose symptoms.

The approval is supported by data from the SEPSIS-SHIELD study, which involved 1,222 patients across 22 sites.

Results displayed high accuracy in diagnosing and predicting outcomes for patients, regardless of their immune status or demographics.

Purvesh Khatri, PhD, co-founder and Chief Scientist of Inflammatix and a Professor of Medicine at Stanford University, described TriVerity as a milestone in precision medicine.

Khatri added that the test's accuracy comes from more than ten years of advanced research and the use of thousands of patient profiles to create reliable systems for analyzing data.

TriVerity offers a potential solution to the challenges of diagnosing and treating acute infections and sepsis.

By enabling faster, more accurate triage and management, the test may improve the efficiency of emergency care.