The U.S. Food and Drug Administration has granted Breakthrough Device designation for T2 Biosystems’ Candida auris (C. auris) direct-from-blood molecular diagnostic test.
This marks the third T2 Biosystems’ product to receive FDA Breakthrough Device designation, as the company was previously granted FDA Breakthrough Device designation for its T2Resistance Panel and T2Lyme Panel. The company plans to expand the test menu on its FDA-cleared T2Dx Instrument by adding the C. auris diagnostic test that is designed to detect C. auris species directly from blood in three to five hours, without the need to wait days for a positive blood culture.
“We are pleased with the FDA’s decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance,” says John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris to the test menu on our FDA-cleared T2Dx Instrument will provide clinicians with a valuable tool to rapidly detect a dangerous, multidrug-resistant fungal pathogen much faster than blood culture-based methods, strengthening our value proposition and increasing the attractiveness of our products to U.S. hospitals.”
Candida auris is a multidrug-resistant fungal pathogen recognized as a serious global health threat with a mortality rate of up to 60%, and is difficult to identify with standard laboratory methods, which can lead to inappropriate treatment.
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.
The company currently markets and sells the T2Candida Panel, an FDA-cleared diagnostic test able to detect sepsis-causing fungal pathogens directly from blood, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the fully-automated T2Dx Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antifungal therapy and improving clinical outcome, the company says.