FDA Grants Breakthrough Designation to Resistance Marker Diagnostic

The FDA granted breakthrough designation to T2 Biosystems’ T2Resistance Panel, a diagnostic tool used to detect a patient’s resistance markers using a single blood sample.

The device cuts through the standard one-to-five day waiting time for positive blood cultures required before testing for microbial susceptibility, allowing physicians to give faster treatment and avoid prescribing drugs that build up antimicrobial resistance.

The diagnostic device detects 13 resistance genes from gram-positive and gram-negative pathogens in three to five hours.