FDA authorises marketing of Inflammatix’s blood test for sepsis diagnosis

The US Food and Drug Administration (FDA) has authorised the marketing of Inflammatix's blood test, the TriVerity Test System, designed to aid in diagnosing individuals with suspected acute infection or sepsis.

The molecular test quantifies the expression levels of 29 genes linked to the body's immune reaction to infection.

By employing ‘validated’ algorithms, which are driven by machine learning and AI, the test produces three distinct scores that assess the probability of bacterial infection, viral infection, and severe illness risk.

The system claims to alleviate the challenges that hospitals face, particularly in emergency departments (EDs) struggling with overcrowding and extended patient stays.

It also claims to provide a measure of infection likelihood and risk stratification and can help potentially reduce unnecessary hospital admissions and improve patient care.

The FDA's authorisation of the system is supported by the findings from the SEPSIS-SHIELD study, which demonstrated the test's ‘high’ diagnostic and ‘prognostic’ accuracy in a diverse patient population.

In November 2023, the system received the FDA's breakthrough device designation.

Inflammatix CEO and co-founder Tim Sweeney said: "The fundamental problem with existing tests is an outdated focus on labelling patients as 'septic or not.' But sepsis is a syndrome, not a disease, and its definition keeps changing."

Developed from research conducted at Stanford University by co-founders Tim Sweeney and Purvesh Khatri, the system incorporates ‘exclusive’ intellectual property licensed by the university.

Headquartered in California, US, Inflammatix focuses on the use of machine learning in molecular diagnostics to interpret the immune response rapidly.

Last November, the company initiated a clinical trial to evaluate the test for managing individuals with suspected acute infection or sepsis.

"FDA authorises marketing of Inflammatix’s blood test for sepsis diagnosis" was originally created and published by Medical Device Network , a GlobalData owned brand.

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