The FDA has granted market clearance for the T2Bacteria Panel, which can identify pathogens associated with sepsis within hours, according to manufacturer T2 Biosystems.
“T2Bacteria is the first and only diagnostic that can identify specific sepsis-causing bacteria directly from a whole-blood specimen in approximately 5 hours without the need to wait for the results of a blood culture,” John McDonough, CEO of T2 Biosystems, said during a teleconference. “This represents a major breakthrough in the field of diagnostics, and more specifically, in the management of patients at risk for sepsis, which continues to be one of the most costly issues both in terms of mortality rate and actual dollars spent in the healthcare system.”
The new assay runs on the FDA-cleared T2Dx Instrument, which can also be used to test and monitor Candida auris infections with the T2Candida Panel (T2 Biosystems). The efficacy of the T2Bacteria Panel was assessed during a clinical trial involving more than 1,400 patients with suspected bloodstream infections at 11 hospitals in the United States.
