Inflammatix Receives FDA Clearance for TriVerity™ Test to Enhance Acute Infection Diagnosis and Triage

Inflammatix has received approval from the U.S. Food and Drug Administration (FDA) for its TriVerity™ Test System, a molecular test designed for patients with suspected acute infection or sepsis. TriVerity combines bacterial and viral infection detection with an assessment of illness severity, providing clinicians with a rapid and comprehensive view of a patient’s condition.

The TriVerity test measures the expression of 29 genes associated with the immune response to infection, using machine learning to calculate three distinct scores: the likelihood of bacterial infection, viral infection, and disease severity (e.g., need for mechanical ventilation or vasopressors within seven days). This helps clinicians diagnose sepsis and evaluate common acute infections such as pneumonia or cellulitis.

“Despite advancements in diagnostic technologies, sepsis remains one of the most challenging and costly diagnoses,” said Dr. Tim Sweeney, CEO and co-founder of Inflammatix. “Existing tests often classify patients as ‘septic or not,’ but sepsis is a syndrome that varies. TriVerity focuses on actionable factors: is there an infection, and how severe is it?”

“The FDA clearance of TriVerity is a significant step forward for emergency departments that face overcrowding and resource constraints,” said Dr. John W. Hafner, MD, emergency medicine physician at OSF HealthCare. “TriVerity offers a faster, more reliable method for triaging patients with ambiguous symptoms, improving care and easing clinician workload.”