Posted by Michael Wonder on 27 Apr 2022
T2 Biosystems announces submission for FDA breakthrough device designation for T2Biothreat Panel
27 April 2022 - T2 Biosystems announced today that it has submitted an application with the U.S. FDA for breakthrough device designation for the Company’s T2Biothreat Panel.
The T2Biothreat Panel is a direct-from-blood test panel designed to run on our commercially available T2Dx Instrument and is designed to simultaneously detect six biothreat pathogens that are listed by the Centers for Disease Control and Prevention (CDC) as Category A and B biothreat agents, including Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis and Rickettsia prowazekii.
The CDC has determined that these organisms represent a national security risk, and they have a mortality rate of approximately 40% for untreated Burkholderia mallei or Burkholderia pseudomallei infections to nearly 90% for untreated for Yersinia pestis infections.
