The test measures 29 messenger RNAs to rapidly assess the body’s immune response to infection. Credit: THICHA SATAPITANON / Shutterstock.

Inflammatix has secured $57m in a Series E financing round to advance its TriVerity acute infection and sepsis test.

Led by Khosla Ventures and Think.Health, the investment aims to support the regulatory filing and early commercialisation of the test, which is designed to address the critical need in the emergency department (ED) setting.

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The funding round, which also saw contributions from Northpond Ventures, Iberis Capital, Vesalius BioCapital, D1 Capital Partners, RAW Ventures, OSF Healthcare and others, brings Inflammatix’s total private capital to over $200m.

This is in addition to grants and contracts worth more than $50m from various government agencies and foundations.

Performed on Inflammatix’s Myrna Instrument, the TriVerity test received breakthrough device designation from the US Food and Drug Administration (FDA) in November 2023.

Capable of multiplex sample-to-answer mRNAs quantitation in about 30 minutes, the Myrna Instrument is designed for ease of use with minimal operator hands-on time and simple maintenance requirements.

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Following the completion of the SEPSIS-SHIELD study [NCT04094818], the company has submitted a regulatory packet to the FDA and anticipates clearance later this year.

The TriVerity test measures 29 messenger RNAs (mRNAs) to rapidly assess the body’s immune response to infection using machine learning-derived algorithms.

It aims to inform physicians about the presence of infection and the risk of progression to severe illness, aiding in critical treatment decisions.

Inflammatix said that the test is not yet available for sale, as it is currently pending clearance from the FDA and has not received approval for marketing or regulatory authorities’ clearance in any jurisdiction.

Inflammatix CEO and co-founder Dr Timothy Sweeney said: “The newly raised funds will help us to expand our commercial team and plan clinical interventional and health economic studies as we await FDA clearance over the coming months.

“TriVerity is bringing the promise of machine learning and AI to infection and sepsis care. We hope to help hospitals improve their performance in terms of complying with sepsis detection and treatment protocols and optimising patient throughput.”