Journal of Clinical Microbiology study validates accuracy, precision and operational usability of FDA-cleared sepsis diagnostic test.
Inflammatix has published analytical validation data in the Journal of Clinical Microbiology demonstrating the performance characteristics of its TriVerity Test System, a molecular blood test designed to help emergency department physicians triage patients with suspected acute infection or sepsis.
The study validates the test’s accuracy, precision, stability and operational usability, with results generated in approximately 30 minutes and requiring less than one minute of hands-on operator time per test. The data support TriVerity’s integration into hospital laboratory workflows for routine clinical decision support.
“The TriVerity Test System demonstrates analytical performance characteristics that meet or exceed regulatory and laboratory standards,” says Natalie N Whitfield, PhD, D(ABMM), senior director of Medical Affairs at Inflammatix and one of the study authors, in a release. “These qualities make the test ideally suited for integration into hospital laboratories that prioritize accuracy, rapid turnaround, and ease of workflow, allowing for routine use in supporting clinical decision-making in emergency departments.”
Test Technology and Clinical Applications
TriVerity measures expression levels of 29 genes associated with host immune response to infection, using artificial intelligence and machine learning algorithms to generate three clinical scores. The test provides likelihood assessments for bacterial infection, viral infection, and severe illness requiring mechanical ventilation, vasopressors, or renal replacement therapy within seven days.
The FDA granted marketing clearance to TriVerity in January 2025 and designated it a Breakthrough Device in November 2023. The test runs on Inflammatix’s Myrna instrument platform using a cartridge-based format designed for point-of-care and laboratory settings.
The published analytical data complement clinical validation results from the company’s SEPSIS-SHIELD study, which Inflammatix says will be published separately. Together, the studies provide implementation guidance for hospitals and health systems adopting the technology.
Market Positioning and Development
“The prompt diagnosis of acute infections and sepsis is critical for improving patient outcomes,” says Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix, in a release. “The data demonstrating the analytical accuracy and robustness of the first-of-its-kind TriVerity Test System, as reported in the Journal of Clinical Microbiology, complement the clinical validation documented in the soon-to-be-published SEPSIS-SHIELD study.”
TriVerity is based on research conducted at Stanford University by co-founders Sweeney and Purvesh Khatri, incorporating intellectual property exclusively licensed from Stanford. The Sunnyvale, California-based company has received funding from Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital and the Stanford-StartX Fund.
Development has been supported in part by federal contracts from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Photo caption: TriVerity
Photo credit: Inflammatix
