T2 Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Detection Test T2
T2 Biosystems, Inc. is a leading company specializing in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes. Their FDA-cleared T2Dx Instrument provides clinicians with valuable tools to quickly identify dangerous, multidrug-resistant fungal pathogens, such as Candida auris, much faster than traditional blood culture-based methods. This enhancement strengthens their product's value proposition and makes it more appealing to U.S. hospitals.
Candida auris is a serious global health threat with a mortality rate of up to 60%. It is a multidrug-resistant fungal pathogen that is challenging to identify using standard laboratory methods, leading to potential inappropriate treatment and poor patient outcomes.
The T2Candida Panel, which runs on the fully-automated T2Dx Instrument, enables simultaneous detection of five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. The rapid detection of these pathogens, along with Candida auris, is crucial in promptly initiating appropriate antifungal therapy, which significantly improves clinical outcomes for infected patients.
By offering a faster and more efficient alternative to conventional methods, T2 Biosystems aims to help healthcare professionals make informed decisions and provide targeted treatments. This approach minimizes the risk of delayed or inappropriate therapy and contributes to better patient care. The addition of Candida auris to their test menu is a vital step in T2 Biosystems' mission to combat multidrug-resistant fungal infections and improve overall patient outcomes.
