FEBRUARY 28, 2019

FDA Grants Breakthrough Device Designation for the T2Resistance Panel

By IDSE News Staff

The FDA granted T2 Biosystems Breakthrough Device designation for the T2Resistance panel, a diagnostic panel that can detect 13 resistance genes from both gram-negative and -positive pathogens from a single blood sample, without the wait for blood culture.

The 13 genes identified with the panel include the most clinically important, as they are largely resistant to antimicrobial drugs that, for certain patients, are crucial in the treatment of bacterial infections, including