T2 Biosystems seeking FDA breakthrough device designation for Candida auris test

Bacteria Blood Sepsis Social

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.

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