T2 Biosystems Applies for FDA Breakthrough Device Designation for Candida Auris Test

 T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted an application with the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for the Company’s Candida auris test. The Company recently announced plans to add C. auris detection to its FDA-cleared T2Candida^® Panel.

Candida auris (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, as it can be difficult to identify with standard laboratory methods, some strains are resistant to all three available classes of antifungals, it spreads easily in healthcare facilities, and can cause severe infections with high death rates. The CDC estimates the costs associated with U.S. fungal diseases, in general, are as high as $48 billion annually, and has called on public health professionals to help lower the burden of fungal disease by continuing to raise awareness of the life-saving benefits of early detection and proper treatment.

https://www.biospace.com/article/releases/t2-biosystems-announces-submission-for-fda-breakthrough-device-designation-for-candida-auris-diagnostic-testcompany-plans-to-add-multidrug-resistant-candida-auris-detection-to-its-fda-cleared-t2candida-panel/