Rapid Host-Response Test Aims to Predict Corticosteroid Benefit in Sepsis

Sepsis and severe infections are difficult to treat because patients with similar clinical presentations may have very different underlying immune responses. Corticosteroids are commonly used in severe infection, septic shock, viral pneumonia, and pandemic settings, but treatment benefit can vary considerably between patients. To better guide therapy, a newly evaluated host-response approach aims to identify patients with severe infection or suspected sepsis who may be more likely to benefit from corticosteroids.

Inflammatix, Inc. (Sunnyvale, CA, USA) has received a $1 million development contract from the Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response. The contract will support Project Compass, which will evaluate the TriVerity host-response test as a platform for predicting corticosteroid responsiveness in patients with severe infections and suspected sepsis. TriVerity is cleared by the U.S. Food and Drug Administration (FDA) for its current diagnostic and triage use, but use of TriVerity to predict response to corticosteroid therapy is investigational and has not been cleared or approved by the FDA.

The TriVerity Test System includes a disposable TriVerity cartridge and the Myrna instrument. The test measures 29 host messenger RNAs from whole blood and uses machine learning-derived algorithms to interpret the body’s immune response to infection. In approximately 30 minutes, it generates three scores indicating the likelihood of bacterial infection, likelihood of viral infection, and illness severity in adult emergency department patients with suspected acute infection or sepsis.

Project Compass builds on earlier retrospective analyses of independent sepsis clinical trial datasets that suggested corticosteroid response may differ according to TriVerity illness severity classification. Patients in the highest Illness Severity band appeared more likely to experience clinical benefit from corticosteroid therapy, while those in lower severity bands may derive less benefit and could potentially be harmed. The new project will further evaluate this hypothesis in well-characterized patient cohorts, both on-device using the FDA-cleared Myrna platform and in silico using locked TriVerity algorithms.

“Inflammatix was founded on a simple belief: the body often knows more about disease than we can currently see. With Project Compass, we are asking an important next question: can we use that immune signal not only to understand infection and severity earlier, but also to help determine which therapy is right for which patient? If successful, this work could move sepsis care beyond broad, one-size-fits-all treatment and toward real-time, host-response-guided precision medicine,” said Tim Sweeney, MD, PhD, co-founder and CEO of Inflammatix.

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