Summary by Moomoo AI
On September 9, 2024, T2 Biosystems, a leader in rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced updates on its product development pipeline. The company is finalizing a 510(k) premarket notification for the T2Resistance Panel, which is expected to be filed with the FDA in Q4 2024. The T2Resistance Panel, which detects 13 antibiotic resistance genes directly from blood, has been highlighted for its high accuracy and rapid results in a recent study. T2 Biosystems is also awaiting FDA clearance for its T2Candida Panel to detect pediatric Candida infections and is planning to submit a 510(k) for the T2Bacteria Panel for pediatric bacterial infections. The company has shifted its strategy for the T2Lyme Panel, opting to build or buy its own laboratory for testing instead of partnering, which may delay its launch. Additionally, T2 Biosystems is seeking non-dilutive funding to complete development of a test for Candida auris, in collaboration with the CDC. The company's pipeline products, which have received FDA Breakthrough Device designation, aim to enable faster treatment and improve patient outcomes by detecting pathogens directly from blood.
