Inflammatix Completes Technical Development for TriVerity™ Acute Infection and Sepsis Test System
Inflammatix, Inc., an innovative molecular diagnostics company, announced today the successful completion of technical development for its TriVerity™ Acute Infection and Sepsis Test System.
This comprehensive system, which includes the Myrna™ Instrument and the TriVerity™ Cartridge, is designed for use in emergency department settings for patients with suspected acute infection and sepsis. It aims to assess the likelihood of a bacterial or viral infection and the risk of acute decompensation, indicating the need for intensive care.
Dr. Timothy Sweeney, CEO and co-founder of Inflammatix, expressed excitement about Myrna becoming the world’s highest-multiplex point-of-care system capable of quantitating RNA. This capability brings precision medicine into acute care settings. The completion of technical development is a significant milestone, bringing TriVerity closer to FDA submission and launch, facilitating crucial clinical studies.
The Myrna Instrument can quantitate up to 64 messenger RNAs (mRNAs) from various sample types in approximately 30 minutes, with CLIA-waivable design for point-of-care use. The disposable cartridges are expected to remain stable at room temperature for up to 12 months.
Dr. Sweeney anticipates exploring partnerships to integrate existing RNA signatures onto the Myrna ecosystem, a pathway potentially influenced by evolving regulations for lab-developed tests and the growing reliance on biomarker-driven approaches to immunotherapy development.
Inflammatix’s lead product, the TriVerity Acute Infection and Sepsis Test, utilizes a panel of 29 mRNAs to analyze the body’s immune response, aiding in the diagnosis of patients with suspected acute infection and sepsis in U.S. emergency departments. The company estimates that around 20 million patients annually present symptoms consistent with suspected infection in emergency departments.
The company has resumed its clinical studies, including the SEPSIS-SHIELD study (NCT04094818), crucial for FDA submission of the TriVerity Test system. With 955 patients already enrolled out of an estimated 1,500 needed, Inflammatix expects study completion and FDA submission by spring 2024.
It’s important to note that the TriVerity Acute Infection and Sepsis Test System is still in development, not available for sale, and lacks marketing approval or clearance from regulatory authorities in any jurisdiction.
