Image created by Dr. Michael J. Miller
Sunnyvale, CA-based Inflammatix has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its TriVerity rapid sepsis test system, according to the company.
The point-of-care molecular test, designed to sideline traditional blood culture, is a host response test that measures mRNA expression using artificial intelligence (AI). TriVerity combines bacterial-viral infection scoring with a severity risk evaluation.
The test measures the expression levels of 29 genes associated with the host immune response to infection. AI and machine learning then 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), Inflammatix explained.
"The fundamental problem with existing tests is an outdated focus on labeling patients as 'septic or not,'" Inflammatix CEO and Co-Founder Dr. Tim Sweeney, PhD, said. "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??"
In November 2023, the FDA granted Triverity the breakthrough device designation for the system, which comprises the Myrna instrument and the test. FDA marketing authorization of TriVerity is based on results from the Sepsis Shield study, Inflammatix said.
In September 2024, Inflammatix raised $57 million in series E financing, led by Khosla Ventures and Think.Health Ventures, with participation from Northpond Ventures, D1 Capital Partners, Iberis Capital, Vesalius BioCapital, OSF Healthcare, RAW Ventures, and others. The funding round brought total private capital raised to more than $200 million, the company reported.
Inflammatix has also benefited from at least $50 million in grants and contracts from various government agencies, such as the U.S. Biomedical Advanced Research and Development Authority and foundations, the company said.