T2 Biosystems receives FDA clearance to market T2Candida Panel for pediatric patients, detecting sepsis-causing Candida species directly from blood in 3-5 hours, faster and more sensitive than blood culture.
T2 Biosystems received FDA Breakthrough Device designation for its Candida auris test, aiming to detect the pathogen directly from blood in 3-5 hours. This designation may expedite FDA clearance, enhancing rapid detection of multidrug-resistant fungal pathogens, crucial for timely treatment and improving clinical outcomes.