Inflammatix, Inc., a molecular diagnostics company, today announced an important milestone with the completion of technical development for its TriVerity Acute Infection and Sepsis Test System.
The system is comprised of the company’s Myrna Instrument and the TriVerity Cartridge. 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. It is designed to be Clinical Laboratory Improvement Amendments (CLIA)-waivable to enable point-of-care deployments. The disposable TriVerity Cartridges are expected to be room-temperature stable for up to 12 months.
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.
“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,” said Dr. Timothy Sweeney, 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 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.
Inflammatix product development has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA). The TriVerity Acute Infection and Sepsis Test System is a product in development, is not currently for sale, and does not have marketing approval or clearance from regulatory authorities in any jurisdiction.
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