T2 Biosystems Submits Candida Auris Diagnostic Test for FDA Breakthrough Device Designation

T2 Biosystems has submitted an application for Breakthrough Device Designation with the U.S. Food and Drug Administration (FDA) for the Candida auris test.

Candida auris, or C. auris, is a fungal pathogen that has been identified as a serious global health threat by both the Centres for Disease Control and Prevention (CDC) and the World Health Organisation (WHO). It is known for its multidrug-resistant nature and high mortality rate, which can reach up to 60%.

The addition of multidrug-resistant Candida auris detection to the FDA-cleared T2Candida Panel will provide clinicians with even more comprehensive and rapid results. By directly detecting these pathogens from blood samples within a few hours, without the need to wait for a positive blood culture, can potentially expedite the diagnosis and treatment of patients with sepsis.

By accurately and quickly identifying C. auris, healthcare professionals can initiate appropriate treatment strategies, potentially reducing the spread of the pathogen and improving patient outcomes.

C. auris to the T2Candida Panel will provide clinicians with rapid results, enabling targeted antimicrobial treatment, which is aligned with CDC’s call to action.