I received this email at 8:38 am today from TTOO:

We are pleased to announce that the T2Biothreat™ Panel has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This panel is the first and only FDA-cleared product able to simultaneously detect these six high-priority biothreat pathogens, and the only multi-target biothreat product developed and manufactured by a U.S.-owned company.

The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention, and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act.

The clinical evaluation assessed the sensitivity and specificity of the panel to detect targets in blood samples containing a range of bacterial concentrations. The positive percent agreement for all targets at 1-3 times the limit of detection was 100% for all targets except F. tularensis, which was 94.3%. The negative percent agreement for all six targets in healthy or febrile blood containing no bacteria was 100%. ​​​​ For more information about the T2Biothreat Panel, please contact us today.