NEWS
T2 Biosystems Provides Updates on its New Product Development Pipeline Progress
T2 Biosystems (NASDAQ:TTOO) has provided updates on its new product development pipeline, focusing on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Key highlights include:
1. Finalizing a 510(k) application for the T2Resistance® Panel, planned for Q4 2024 FDA submission.
2. Pending FDA clearance for expanded use of the T2Candida® Panel for pediatric Candida infections.
3. Plans to submit a 510(k) for expanded use of the T2Bacteria® Panel for pediatric bacterial infections.
4. Decision to build or buy a laboratory for launching the T2Lyme™ Panel as a Laboratory Developed Test.
5. Pursuing non-dilutive funding for a Candida auris diagnostic test.
The company expects to launch multiple new products in 2024 and 2025, with three pipeline products having received FDA Breakthrough Device designation.
1. Finalizing a 510(k) application for the T2Resistance® Panel, planned for Q4 2024 FDA submission.
2. Pending FDA clearance for expanded use of the T2Candida® Panel for pediatric Candida infections.
3. Plans to submit a 510(k) for expanded use of the T2Bacteria® Panel for pediatric bacterial infections.
4. Decision to build or buy a laboratory for launching the T2Lyme™ Panel as a Laboratory Developed Test.
5. Pursuing non-dilutive funding for a Candida auris diagnostic test.
The company expects to launch multiple new products in 2024 and 2025, with three pipeline products having received FDA Breakthrough Device designation.
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