Direct-From-Blood Molecular Diagnostic Test Detects Candida Auris in Just 3-5 Hours

By LabMedica International staff writers
Posted on 21 Jul 2023

Image: The Candida Auris diagnostic test has received FDA Breakthrough Device Designation (Photo courtesy of T2 Biosystems)

Candida auris (C. auris) is a fungal pathogen resistant to multiple drugs and is recognized as a significant worldwide health risk due to its high mortality rate of up to 60%. Its identification is challenging with conventional lab techniques, often leading to improper treatment. To reduce the burden of this fungal disease, public health officials are being urged to continue promoting the crucial benefits of early detection and appropriate treatment. Now, a direct-from-blood molecular diagnostic test can detect C. auris directly from blood in just 3-5 hours, eliminating the need to wait for several days for a positive blood culture.

T2 Biosystems’ (Lexington, MA, USA) C. auris direct-from-blood molecular diagnostic test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This is the third product from T2 Biosystems to receive FDA Breakthrough Device designation after the company's T2Resistance Panel and T2Lyme Panel previously received the same designation. The company intends to expand its FDA-approved T2Dx Instrument's test options by including the C. auris diagnostic test, designed to detect C. auris directly from the blood within 3-5 hours, thus eliminating the days-long wait for a positive blood culture.

Currently, T2 Biosystems markets and sells the T2Candida Panel, the only FDA-approved diagnostic test capable of detecting sepsis-causing fungal pathogens directly from blood, thereby eliminating the need to wait for days for a positive blood culture. The T2Candida Panel, which runs on the fully automated T2Dx Instrument, can simultaneously detect five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as C. auris, is critical to ensuring infected patients receive suitable antifungal therapy, enhancing clinical outcomes.

"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,” said 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.”

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T2 Biosystems