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FDA grants breakthrough device designation to Inflammatix’s TriVerity Acute Infection and Sepsis Test System

Betsy Goodfellow | November 29, 2023 | News story | Research and Development FDA, Infections and infestations, Inflammatix, TriVerity, infection, sepsis 

Inflammatix has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s lead product, TreVerity Acute Infection and Sepsis Test System, which is currently in development.

The test system is intended to be used in emergency departments in adult patients who have suspected acute infection or suspected sepsis, having been designed to provide three independent readouts reflecting the chance of bacterial and viral infections and the risk of severe illness.

This test utilises a panel of 29 messenger RNAs (mRNAs) to ‘read’ immune responses and providing three readouts to be used for the diagnosis and prognosis of adult patients who have suspected acute infection or sepsis.

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Dr Timothy Sweeney, chief executive officer and co-founder of Inflammatix, commented: “We are pleased that the FDA has granted its Breakthrough Device Designation to TriVerity, as it reflects that this novel test system has the potential to help physicians improve on the current standard of care. By reaching this important regulatory milestone, we hope to place TriVerity on an accelerated pathway to FDA clearance, which would allow us to fill an unmet need for rapid, accurate tests for the diagnosis and prognosis of patients with suspected sepsis.”

Betsy Goodfellow

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