Molecular diagnostics company Inflammatix has closed a $57 million funding round, which will support the company's plans for regulatory filing with the FDA and early commercialization of its flagship product, the TriVerity Acute Infection and Sepsis Test (TriVerity).
The company said the funding round brings Inflammatix’s total private capital raised to more than $200 million, in addition to more than $50 million in grants and contracts from various government agencies and foundations.
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TriVerity is a blood test designed for emergency departments (ED) dealing with patients with acute infection or sepsis, a leading cause of death in U.S. hospitals. Inflammatix said it has sponsored clinical studies that show that physician assessment and vital-signs-based scoring often underestimate the severity of infections.
TriVerity is performed on Inflammatix’s Myrna Instrument, which was designed to simultaneously determine if an infection is present and how likely a patient will need to be admitted to the ICU for proper treatment. Earlier and more accurate diagnoses obviously help patients but Inflammatix said they may also help hospitals comply with the CMS SEP-1 Bundle, a value-based payments quality measure intended to ensure rapid sepsis detection and treatment.
After receiving Breakthrough Device Designation from the FDA in November 2023 and completing the SEPSIS-SHIELD study, Inflammatix recently submitted a regulatory packet to the FDA for the TriVerity Test. The company hopes to receive FDA clearance later this year.
