FDA Grants Breakthrough Device Designation to Inflammatix for TriVerity™ Acute Infection and Sepsis Test System
Inflammatix, an innovative molecular diagnostics company, recently achieved a significant milestone as the FDA granted Breakthrough Device Designation to its flagship product, the TriVerity™ Acute Infection and Sepsis Test System. This cutting-edge system, currently in the development phase, comprises the Myrna™ Instrument and the TriVerity Test, designed specifically for adult patients suspected of having acute infection or sepsis in emergency departments.
The TriVerity Test is engineered to provide three distinct readouts, offering insights into the likelihood of bacterial or viral infection and assessing the risk of severe illness. Acknowledged as a Breakthrough Device by the FDA, the TriVerity system has the potential to qualify for the Centers for Medicare & Medicaid Services (CMS) New Technology Add-On Payment (NTAP) program. This program could provide a partial subsidy for hospitals implementing TriVerity Acute Infection and Sepsis Tests on admitted patients for up to three years.
Furthermore, pending the finalization of CMS's proposed Temporary Coverage for Emerging Technologies (TCET) rule, the TriVerity Test may be eligible for temporary coverage for tests conducted on discharged Medicare patients for a period of up to four years.
The TriVerity™ Acute Infection and Sepsis Test System, Inflammatix's flagship product, utilizes a panel of 29 messenger RNAs (mRNAs) to analyze the body's immune response. This enables the diagnosis and prognosis of adult patients presenting with suspected acute infection or sepsis in U.S. emergency departments. The Myrna Instrument, a crucial component of the system, facilitates sample-to-answer quantitation of up to 64 mRNAs from various sample types in approximately 30 minutes. While the initial version of the Myrna Instrument requires standard laboratory operation, Inflammatix has outlined plans for the development of a Clinical Laboratory Improvement Amendments (CLIA)-waivable version to enable future point-of-care deployments.