Inflammatix has commenced a clinical trial to evaluate its TriVerity test, a novel diagnostic tool designed to improve the management of patients with suspected acute infection or sepsis. The TIMED trial (NCT06637904) will assess the impact of TriVerity on clinical decision-making and patient outcomes in emergency department settings.
TriVerity Test: mRNA-Based Immune Response Profiling
The TriVerity test is a blood-based assay that measures the expression levels of 29 messenger RNAs (mRNAs) to profile the body's immune response to infection. This approach allows for rapid identification of the type of infection and assessment of the risk of sepsis. Using Inflammatix's Myrna, a cartridge-based benchtop analyzer, clinicians can obtain results in approximately 30 minutes.
The insights gained from TriVerity can inform decisions regarding antimicrobial therapy, the need for additional diagnostic testing, and the necessity of hospital admission. Accurate and rapid diagnosis of infection is increasingly important due to rising antibiotic resistance, making tools like TriVerity valuable for both individual patient care and broader healthcare system management.
TIMED Trial Design and Objectives
The TIMED trial plans to enroll 600 patients in emergency departments located in Maryland and Illinois. The primary endpoints of the study are compliance with the Severe Sepsis and Septic Shock Management (SEP-1) Bundle and the time to patient admission or discharge. Secondary outcomes include the use of antibiotics and antivirals, length of stay in the emergency department, and diagnostic ordering practices.
The study is being conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE) as Inflammatix pursues clearance for TriVerity and Myrna. The company hopes to secure FDA clearance before the end of the year through the breakthrough device designation pathway.
Expert Commentary
According to John W. Hafner, co-lead investigator of the TIMED study, "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. 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."
Financial Context
Inflammatix recently secured $57 million in Series E financing, adding to the $102 million raised in a Series D round in 2021. These funds are intended to support the commercialization of the TriVerity test.
