FDA Awards T2 Biosystems Breakthrough Status for Candida Auris Test

T2 Biosystems, Inc., a prominent entity in the rapid detection of sepsis-causing pathogens and antibiotic-resistance genes, recently made headlines by securing the U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its Candida auris (C. auris) direct-from-blood molecular diagnostic test. This achievement is particularly noteworthy as it marks the third time T2 Biosystems has received such a designation from the FDA, with the previous recognitions being for its T2Resistance® Panel and T2Lyme™ Panel.   The significance of this designation lies in the capabilities of Read More +