FDA Rejects T2 Biosystems’ T2Biothreat Panel for Breakthrough Device Designation

T2 Biosystems said the FDA rejected the company’s application for Breakthrough Device designation for its T2Biothreat panel.

In a Securities and Exchange Commission filing, the company said it is continuing with a clinical trial for the diagnostic, which it expects to complete in 2022, and that it believes the data from the U.S. trial may enable it to file for FDA clearance later this year.

The blood test panel, which runs on the company’s T2Dx instrument, can simultaneously detect six biothreat pathogens that are listed by the Centers for Disease Control and Prevention, including Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis and Rickettsia prowazekii.

Lexington, Mass.-based T2 Biosystems specializes in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes.