
T2 Biosystems said Monday it has applied to the U.S. Food and Drug Administration (FDA) for breakthrough device designation for its Candida auris test.
The Lexington, MA-based maker of a molecular platform and tests for sepsis and other bloodstream infections recently announced plans to add C. auris detection to its FDA-cleared T2Candida Panel.
John Sperzel, chairman and CEO of T2 Biosystems, noted in a statement that its T2Candida Panel is the only FDA-cleared diagnostic test to detect sepsis-causing fungal pathogens directly-from-blood in three to five hours without the need for a positive blood culture.
C. auris is a multidrug-resistant fungal pathogen with a mortality rate of up to 60% that has been labeled as a serious global health threat by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). The CDC has deemed C. auris as an urgent antimicrobial-resistant threat. The pathogen can be difficult to identify with standard laboratory methods. Some strains are resistant to all three available classes of antifungals, and spread easily in healthcare facilities.