Inflammatix, a molecular diagnostics company, has completed technical development for its TriVerity Acute Infection and Sepsis Test System, which includes the Myrna Instrument, and the TriVerity Cartridge. TriVerity is intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral infection, and risk of acute decompensation (the need for ICU-level care).
“Myrna will be the world’s highest-multiplex point-of-care system capable of quantitating RNA, allowing us to bring ‘precision medicine’ into acute care settings,” says Timothy Sweeney, MD, PhD, CEO and co-founder of Inflammatix. “Completing technical development brings TriVerity a step closer to FDA submission and launch, and enables us to execute key clinical studies.”
The Myrna Instrument is capable of sample-to-answer quantitation of up to 64 messenger RNAs (mRNAs) from whole blood or other sample types in about 30 minutes, the company says. It is designed to be Clinical Laboratory Improvement Amendments (CLIA)-waivable to enable point-of-care deployments. The disposable cartridges are expected to be room-temperature stable for up to 12 months.
“With the completion of the test system, we look forward to further exploring partnerships that bring existing RNA signatures onto the Myrna ecosystem,” says Sweeney. “This may be an especially viable pathway given expected changes to the regulation of lab-developed tests and the increased reliance on a biomarker-driven approach to immunotherapy development.”
The TriVerity Acute Infection and Sepsis Test, Inflammatix’s lead product, incorporates a panel of 29 mRNAs to “read” the body’s immune response and thus aid in the diagnosis of patients with suspected acute infection and sepsis. It is designed to potentially facilitate diagnosis of patients with suspected infection that present in US emergency departments. Based on internal analysis of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP) database, Inflammatix estimates roughly 20 million patients per year visit emergency departments with symptoms consistent with suspected infection.
The company has resumed completion of its clinical studies, including its SEPSIS-SHIELD study (NCT04094818) required for submission of the TriVerity Test system to the U.S. Food and Drug Administration (FDA). The multi-center study has already enrolled 955 of the estimated 1,500 patients needed. Inflammatix estimates study completion and FDA submission to occur by spring 2024.
Further reading: BARDA Further Funds Inflammatix ViraBac EZ Acute Infection Test
The TriVerity Acute Infection and Sepsis Test System is a product in development, is not for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.
Featured image: TriVerity Acute Infection and Sepsis Test System. Photo: Inflammatix