TTOO - T2 Biosystems files for FDA approval of T2Biothreat panel

2023-05-23 09:13:27 ET

T2 Biosystems ( NASDAQ: TTOO ) said it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its T2Biothreat panel to detect certain biothreat pathogens.

The FDA filing follows a recently completed U.S. clinical evaluation which showed very high sensitivity and specificity, and included 350 contrived positive samples and over 470 negative blood samples from healthy and febrile people, according to T2

The company noted that the T2Biothreat Panel is a fully-automated, direct-from-blood test aimed to run on the FDA-cleared T2Dx Instrument, and simultaneously detects six biothreat pathogens identified as threats by the U.S. Centers for Disease Control and Prevention (CDC).

The organisms include, those which cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii).

"We believe the T2Biothreat Panel demonstrates very high sensitivity and specificity for a direct-from-blood multi-target biothreat product, the only such product developed by a U.S.-owned company, and we look forward to working through the FDA premarket review process to obtain clearance," said T2's Chairman and CEO John Sperzel.

The company added that the project has been funded in whole or in part with funds from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA).

In a separate release, T2 reported its Q1 results which missed estimates.

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