The diagnostic products maker has designed the Candida auris test to identify C. auris species from blood in three-five hours, thereby removing the need to wait days to receive a positive blood culture
FDA grants breakthrough status to T2 Biosystems’ Candida auris test. (Credit: National Cancer Institute on Unsplash)
T2 Biosystems has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Candida auris (C. auris) direct-from-blood molecular diagnostic test.
The US-based diagnostic products maker has designed the Candida auris test to identify C. auris species, a multidrug-resistant fungal pathogen.
The test directly detects the species from blood in three-five hours, thereby removing the need to wait days to receive a positive blood culture.
T2 Biosystems chairman and CEO John Sperzel said: “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.
“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.”
The diagnostic products maker’s T2Resistance Panel and T2Lyme Panel were previously given FDA breakthrough device status. This makes Candida auris the third product of the company to gain this designation.
Currently, the company markets and sells its T2Candida Panel, the only diagnostic test approved by the FDA that can quickly identify sepsis-causing fungi in blood without the necessity for a positive blood culture.
It can detect five Candida species, including candida albicans, candida tropicalis, candida parapsilosis, candida krusei, and candida glabrata using the fully automated T2Dx Instrument, the diagnostic products maker added.
T2 Biosystems also has an active pipeline of future products, including the T2Biothreat Panel and T2Lyme Panel.
The company is also planning to launch next-generation products to detect bacterial and fungal pathogens and associated antimicrobial resistance markers.