Inflammatix has secured the FDA’s blessing for its in vitro diagnostic system, aimed at rapidly profiling the body’s response to an infectious disease at the point of care.
With results in about 30 minutes, the benchtop TriVerity test is designed to help emergency department clinicians determine whether a patient is fighting off a bacterial or viral infection, and to see if they may be at risk for developing sepsis.
Known as a host-response diagnostic, the cartridge-based blood test and Myrna instrument platform scans for about 30 genetic biomarkers that are activated by the body’s immune system as it fights off an invader.
With the patterns varying based on the type of bug and its potential severity, the former Fierce Medtech Fierce 15 winner hopes to help guide patient triage and the proper use of antibiotics—and have immune-profiling approaches become as ubiquitous for infection symptoms as troponin tests have been for checking heart muscle damage among patients with chest pain.
“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,” co-founder and CEO Tim Sweeney said in a statement.
“The fundamental problem with existing tests is an outdated focus on labeling patients as ‘septic or not.’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,” Sweeney said. “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?”
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Last September—as Inflammatix was awaiting TriVerity’s 510(k) clearance review at the FDA—the company raised $57 million in new venture capital financing to help grow its commercial staff in preparation for the test’s launch. It has estimated that about 20 million people each year enter ERs with acute infection symptoms.
“As a former CEO of multiple large-scale health systems, I’ve seen how slow or inaccurate sepsis diagnosis harms patient care, drives up costs, and contributes to clinician burnout,” said Hal Paz, operating partner at Khosla Ventures, which co-led Inflammatix’s series E round last fall. “TriVerity transforms that equation by reducing diagnostic uncertainty, streamlining care, lowering costs, and most importantly improving patient outcomes.”
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Last fall also saw sepsis test developer Cytovale collect $100 million to support the launch of its FDA-cleared IntelliSep system. That diagnostic works differently: By physically squeezing white blood cell samples and observing the reactions, the eight-minute diagnostic can assign patients to one of three risk groups based on their chances of developing sepsis in the following three days.
Meanwhile, in April 2024, Prenosis received a de novo clearance from the FDA for its ImmunoScore software designed to spot patients at the highest risk for sepsis, using 22 biomarkers plus clinical data taken from electronic health records.
