T2 Biosystems receives FDA clearance to market the T2Candida Panel

T2 Biosystems announced that it has received clearance from the U.S. Food and Drug Administration, FDA, to market its FDA-cleared T2Candida Panel for pediatric patients. The Company expects to immediately begin marketing and selling the T2Candida Panel under the expanded pediatric claim. “This FDA clearance marks another important milestone in our commitment to expand the clinical utility of our sepsis test panels and allows our commercial team to immediately begin marketing and selling our test to over 200 children’s hospitals in the U.S.,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Studies show that the T2Candida Panel detects Candida species significantly faster, and with greater sensitivity, when compared to blood culture-based diagnostics, and we believe the new pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.”