Medical Device Network

Inflammatix begins trial evaluating mRNA test for patient infection status

With a test currently under FDA review, Inflammatix commences a 600 patient-strong clinical trial in emergency departments.

Not long after netting $57m in financing, Inflammatix has kick started a clinical trial evaluating its technology for the management of patients with suspected acute infection or sepsis.

The TIMED trial (NCT06637904) will use the US company’s TriVerity test – a blood-based test that measures 29 messenger RNAs (mRNAs) to rapidly gain insight into the body's immune response to infection. When analysed on the Inflammatix’s cartridge-based, benchtop analyser called Myrna, emergency department clinicians can find out what type of infection a patient has, and whether sepsis is a potential consequence.

Results come through in about 30 minutes, and the findings from TriVerity can help decide which antimicrobial therapy a patient should receive, any additional diagnostic testing that might be needed, and whether a hospital stay is required.

Accurate diagnosis of infection, and risk of progression to severe illness, is gaining importance in light of rising resistance to antibiotics. Rapidly gaining insights into infection status in patients not only helps on an individual level therefore, but also on a macro health system level.

Inflammatix plans to enrol 600 patients in the TIMED trial, which will be conducted at emergency departments in Maryland and Illinois. The primary endpoints are compliance with the Severe Sepsis and Septic Shock Management (SEP-1) Bundle and time to patient admission or discharge. Secondary outcomes will include use of antibiotics and antivirals, length of stay at the emergency department, diagnostic ordering practices, amongst other hospital measures.

The study is being conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE) whilst Inflammatix waits on potential clearance for TriVerity and Myrna. Inflammatix previously said it hopes to receive clearance from the FDA before the end of this year, with its products under review via the breakthrough device designation pathway.

Inflammatix previously raised $102m in series D financing in 2021, followed by $57m in Series E financing two months ago to help with commercialisation of the test.

"For many patients whose presentations are difficult to differentiate, the limitations of existing diagnostics make it extremely challenging to diagnose the presence, type, and severity of infection," said TIMED study co-lead investigator John W. Hafner.

"That challenge has multiple ramifications, including suboptimal compliance with the SEP-1 Bundle and lengthy emergency department wait times and stays. The TIMED trial, with its pre- and post-interventional design, will allow us to evaluate the impact of the novel TriVerity test on these and other important clinical parameters in real time."