T2 Biosystems gets FDA clearance for T2Biothreat Panel

Received FDA 510(k) clearance for the T2Biothreat(TM) Panel, a direct-from-blood diagnostic test; only FDA-cleared multi-target biothreat test developed/manufactured by a U.S. owned company. Received FDA Breakthrough Device designation for Candida auris test, a direct-from-blood molecular diagnostic test, marking the third T2 Biosystems’ product to receive this designation. Advanced the T2Resistance Panel toward FDA 510(k) submission, which we expect to occur during the first quarter of 2024. Filed FDA 510(k) submission to expand the FDA-cleared T2Bacteria Panel to include the detection of Acinetobacter baumannii. The Company’s milestone-based product development contract with BARDA ended on September 15 3. “Our third quarter results were highlighted by the receipt of FDA 510(k) clearance for the T2Biothreat Panel and 510(k) submission to add Acinetobacter baumannii detection to the FDA-cleared T2Bacteria Panel, which are both intended to create growth opportunities by expanding the test menu on our FDA-cleared T2Dx Instrument,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Operationally, we have taken aggressive measures to address the sepsis test backorder, we have significantly improved our balance sheet by raising capital and by reducing our debt, and we have taken steps to maintain our Nasdaq listing, all of which will allow the Company to further advance our corporate priorities.”