US-based molecular diagnostics company Inflammatix has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its TriVerity acute infection and sepsis test system.

Currently under development, the TriVerity test system is the lead product for Inflammatix and comprises the Myrna Instrument and the TriVerity Test.

Myrna Instrument is designed with a capacity to quantitatively sample-to-answer up to 64 mRNAs from whole blood or other sample types in about 30 minutes.

The test includes a panel of 29 mRNAs that read the body’s immune response and is intended for use in emergency departments, for adult patients with suspected acute infection or sepsis.

It is designed to provide three independent readouts that indicate either a bacterial infection, viral infection, or the risk of severe illness, said the diagnostics company.

Inflammatix CEO and co-founder Timothy Sweeney said: “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.”

Sweeney added: “The potential Medicare reimbursement benefits associated with Breakthrough Designation may expedite implementation of TriVerity in our partner hospitals. We continue to engage with payers, hospitals, and other stakeholders on our path to commercial launch.”

Inflammatix recently announced the completion of technical development for the TriVerity test system and has resumed its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for 510(k) clearance of the TriVerity test system by the FDA.

The multi-centre study has already enrolled 955 of the estimated 1,500 patients targeted. The company estimates study completion and FDA submission to occur in 2024.

The FDA’s Breakthrough Devices designation is intended to speed up the development, assessment, and review of certain medical device products for authorisation.

As a Breakthrough Device, TriVerity is eligible for the Centres for Medicare and Medicaid Services (CMS) New Technology Add-On Payment (NTAP) programme.

The NTAP enables the company’s future customers to receive a partial subsidy for purchases of TriVerity Acute Infection and Sepsis Tests performed on admitted patients, for up to three years.

In addition, the TriVerity Test may be eligible for temporary coverage for tests performed on discharged Medicare patients for up to four years, subject to CMS finalising its proposed Temporary Coverage for Emerging Technologies (TCET) rule.