T2 Biosystems Provides Updates on its New Product Development Pipeline Progress
T2 Biosystems updates on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Key plans include finalizing a 510(k) for the T2Resistance® Panel by Q4 2024, pending FDA clearance for the T2Candida® Panel for pediatric use, and submitting a 510(k) for the T2Bacteria® Panel for pediatric bacterial infections. The company also decides to build or buy a lab for the T2Lyme™ Panel and seeks non-dilutive funding for a Candida auris test. Three pipeline products have received FDA Breakthrough Device designation, with multiple new product launches expected in 2024-2025.
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T2 Biosystems updates on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Key plans include finalizing a 510(k) for the T2Resistance® Panel by Q4 2024, pending FDA clearance for the T2Candida® Panel for pediatric use, and submitting a 510(k) for the T2Bacteria® Panel for pediatric bacterial infections. The company also decides to build or buy a lab for the T2Lyme™ Panel and seeks non-dilutive funding for a Candida auris test. Three pipeline products have received FDA Breakthrough Device designation, with multiple new product launches expected in 2024-2025.