HomeBusiness & MoneyFDA grants breakthrough status to T2 Biosystems C. auris test (NASDAQ:TTOO)

FDA grants breakthrough status to T2 Biosystems C. auris test (NASDAQ:TTOO)


Iryna Drozd

T2 Biosystems (NASDAQ:TTOO) has received breakthrough device status from the US Food and Drug Administration for its Candida auris molecular diagnostic blood test. 

The test is designed to detect C. auris, a multi-drug resistant fungal pathogen, in three to five hours, without the need to wait days for a blood culture, T2 Biosystems said. 

More on T2 Biosystems:

T2 Biosystems reports Q2 revenue and FY23 guidance

T2 Biosystems stock soars on conversion of 20% of CRG term loan into equity

T2 Biosystems seeks FDA breakthrough designation for C. auris test



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