FDA clears sepsis diagnostic test TriVerity

The California-based molecular diagnostics company Inflammatix has received FDA clearance for its first-in-class sepsis diagnosis blood test, TriVerity^™.

The US FDA has granted Inflammatix (CA, USA) marketing authorization for their TriVerity Test System, designed to aid in diagnosing individuals with acute infection or sepsis. The test uses a precision medicine approach, measuring 29 immune-related gene expressions, along with AI-driven algorithms, to provide a rapid measure of infection likelihood and risk, to ultimately ease the burden on emergency departments.

Arising when the body’s response to an existing infection becomes extreme and damages the vital organs, sepsis is a potentially life-threatening condition that is tricky to spot and must be treated early:

“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,” explained Tim Sweeney, CEO and co-founder of Inflammatix. “The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’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: (1) does this patient have an infection, and (2) how sick are they likely to become?”

TriVerity measures the expression levels of 29 genes associated with the host’s immune response to infection. Using validated algorithms developed using AI/machine learning, the test sorts the host response information into three distinct scores, indicating the likelihood of (1) bacterial infection, (2) viral infection and (3) severe illness requiring critical intervention.

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Clinical benefits

The TriVerity test provides rapid measurement of infection likelihood and risk, triaging patients with acute infections and sepsis, and quickly sorting patients into a ‘grey zone’ if they exhibit ambiguous or hard-to-diagnose symptoms. The test also helps manage patients who have common acute infections such as suspected pneumonia or cellulitis, etc. The long-term goal is to lessen the burden on emergency services by reducing overcrowding and unnecessary hospital admissions.

“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,” said John W. Hafner, 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 (both IL, USA). “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.”

FDA clearance

FDA clearance followed the SEPSIS-SHIELD study, which validated the accuracy of TriVerity’s diagnostics and prognostic results across 1,222 patients. The test previously received FDA Breakthrough Device Designation in 2023.

“TriVerity is a first step towards accurate molecular characterization of acute illnesses,” noted Inflammatix Co-founder and Chief Scientist Purvesh Khatri, and Professor of Medicine at Stanford University (CA, USA). “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.”

Overall, TriVerity provides a new avenue for sepsis and acute infection diagnosis, which Inflammatix hopes will yield benefits to both patients and emergency services.