The test can both identify bacterial and viral infections and assess the need for critical care in patients with suspected infection or sepsis.


RT’s Three Key Takeaways:

  1. FDA Authorization Granted: The US Food and Drug Administration has cleared a new molecular test designed to rapidly assess patients with suspected sepsis or acute infections
  2. Focus on Immune Response: Unlike traditional sepsis tests, the test evaluates the expression of 29 immune-related genes, providing bacterial-viral infection scores and an all-cause illness severity risk to guide clinical decision-making.
  3. Clinical Trial Validates Accuracy: FDA clearance was based on results from the SEPSIS-SHIELD study, which demonstrated the test’s high diagnostic and prognostic accuracy in over 1,200 patients across 22 sites.

California-based Inflammatix today announced that the US Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity test system, a molecular test for patients with suspected acute infection or sepsis. 

Using measurements of a patient’s immune response, TriVerity combines bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status. 

“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 healthcare system,” says Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, in a 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 “The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’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: One, does this patient have an infection, and two, how sick are they likely to become?” 

[RELATED: $100M Funding to Boost Rollout of FDA-Cleared Sepsis Test]

TriVerity is a rapid blood test that measures the expression levels of 29 genes associated with the host immune response to infection. The test uses validated algorithms developed applying artificial intelligence (AI)/machine learning to interpret the host response information into three scores that indicate the likelihood of bacterial infection, viral infection, and severe illness (as defined by the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days).

Potential Benefits for Hospital Workflows

TriVerity is expected to ease the burden faced by hospital systems, which face emergency department overcrowding, and, for those patients admitted, with lengths of stay commonly measured not in hours but in days or even weeks. A large part of the problem is that for every patient identified with sepsis, typically 20 patients must be screened or tested. Faster, more accurate triage of this patient segment may dramatically decrease resource strain, reduce unnecessary hospital admissions and lengths of stay, and free up clinicians to focus on patients who truly need critical interventions. 

[RELATED: FDA Grants Breakthrough Designation to Sepsis Risk Assessment Test]

“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,” says 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 a 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.”

Clinical Validation and Future Impact

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 previously granted Breakthrough Device Designation to TriVerity in November 2023. 

“TriVerity is a first step towards accurate molecular characterization of acute illnesses,” says Inflammatix co-founder and chief scientist Purvesh Khatri, PhD, who is also professor of medicine at Stanford University, in a release. “Its unprecedented accuracy is the result of over a decade of rigorous state-of-the-art data science. We were able to integrate thousands of patient profiles into a set of robust classifiers and were thrilled that the accuracy was exactly in line with our expectations. Our combination of rapid, high-multiplex test results with data-driven insights will usher in the era of precision medicine for critical illnesses in which the immune host response is the determining factor in individualizing care for every patient walking into the emergency department.” 

TriVerity is based on research done at Stanford University by co-founders Sweeney and Khatri, including intellectual property exclusively licensed from Stanford University.

Photo caption: TriVerity test

Photo credit: Inflammatix