Inflammatix Data in Journal of Clinical Microbiology Validate Accuracy, Robustness, and Ease of Use of TriVerity™ Test System

Publication demonstrates superior analytical performance of TriVerity in assessing patients with suspected acute infection or sepsis

SUNNYVALE, Calif., Sept. 2, 2025 /PRNewswire/ -- Inflammatix, a pioneering host response diagnostics company, today announced the publication of analytical data in the Journal of Clinical Microbiology (JCM) that validate the benefits of the TriVerity^™ Test System (TriVerity), a first-in-class molecular blood test to help emergency department (ED) physicians quickly and accurately triage patients with suspected acute infection or sepsis. The data demonstrate the high accuracy and precision, fast turnaround time, and ease of use of TriVerity, as well as the reliability of the Myrna^™ Instrument, on which the test is run.

As reported in JCM, TriVerity provides superior analytical performance in terms of reproducibility, sensitivity, specificity, stability, and operational usability. The test generates results within a clinically meaningful time frame (approximately 30 minutes), with minimal operator hands-on time (under 1 minute per test performed). The analytical data support the use of TriVerity as a reliable and user-friendly tool in helping ED clinicians manage patients with suspected infection and/or sepsis.

"The TriVerity Test System demonstrates analytical performance characteristics that meet or exceed regulatory and laboratory standards," said Natalie N. Whitfield, Ph.D., D(ABMM), senior director of Medical Affairs at Inflammatix, and one of the authors of the JCM paper. "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."

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 artificial intelligence/machine learning (AI/ML) to interpret the host response information into three scores that indicate the likelihood of (1) bacterial infection, (2) viral infection, and (3) severe illness (the need for mechanical ventilation, vasopressors, or renal replacement therapy within seven days). The U.S. Food and Drug Administration (FDA) granted marketing clearance to TriVerity in January 2025, and designated it a Breakthrough Device in November 2023.

In the JCM publication, Dr. Whitfield and colleagues reported the following key performance highlights from their evaluation of patient samples tested via TriVerity:

• A method comparison analysis revealed high concordance with the Nanostring nCounter^® platform, which was used as a reference platform for classifier development and non-registrational clinical trials before TriVerity became available (Pearson coefficient of correlation: 0.91 for bacterial score, 0.93 for viral score, 0.92 for severity score).
• The TriVerity Test System exhibited high precision, with TriVerity score standard deviations (SDs) <5.5 on average for clinical samples across all interpretation bands, each falling within the predefined acceptable limits.
• Lot-to-lot reproducibility analysis revealed SDs below the acceptance criteria of <5.5 across all lots at multiple testing sites, with a Fleiss kappa score of 0.915, indicating high agreement.
• The TriVerity cartridges were stable at room temperature for 9 months and 12 months using accelerated testing at 37⁰ Celsius.
• There was no interference from 17 substances commonly found in the blood of patients with suspected acute infection and/or sepsis, including a broad range of antibiotics, biomarkers, and serum proteins.
• All (100%) 43 respondents to an operator survey found TriVerity easy to perform.

"The prompt diagnosis of acute infections and sepsis is critical for improving patient outcomes," noted Tim Sweeney, MD, PhD, CEO and co-founder of Inflammatix. "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. Together, the findings from these two studies will be highly useful to individual hospitals and health systems implementing the test for patient care."

About the TriVerity^™ Test System

The TriVerity^™ Test System ("TriVerity"), Inflammatix's flagship in vitro diagnostic (IVD) test, includes the TriVerity cartridge and the Myrna^™ instrument. TriVerity incorporates a panel of 29 patient messenger RNAs (mRNAs) to rapidly "read" the body's immune response to infection using machine learning-derived algorithms. TriVerity shows the likelihood of a bacterial infection, a viral infection, and illness severity in adult patients with suspected acute infection or sepsis that present to emergency departments. TriVerity empowers physicians to confidently make care decisions, which could influence the selection of antimicrobial therapy, focused workups with judicious laboratory and imaging orders, and patient admission or discharge disposition.

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

About Inflammatix

Inflammatix, Inc., based in Sunnyvale, California, USA, is revolutionizing molecular diagnostics with machine-learning-powered technology to rapidly read a patient's immune response. Our innovative diagnostics aim to improve patient care and tackle significant public health challenges. Designed for our advanced sample-to-answer isothermal instrument platform, our tests bring the power of precision medicine to the point of care. The company's funders include Khosla Ventures, Northpond Ventures, Think.Health Ventures, D1 Capital Partners, Iberis Capital, and Vesalius BioCapital, and the Stanford-StartX Fund. For more information, please visit www.inflammatix.com and follow the company on LinkedIn and X (formerly Twitter) at @Inflammatix_Inc).

Inflammatix product development has been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract numbers 75A50119C00034, 75A50119C00044, and 75A50122C00069.

TriVerity, Myrna, and Inflammatix are trademarks of Inflammatix, Inc. in the U.S. and other countries and regions.

SOURCE Inflammatix