T2 Biosystems announces FDA 510k submission to expand use of T2Candida panel

T2 Biosystems announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration to expand the use of its FDA-cleared T2Candida Panel to include pediatric testing. “This FDA submission marks another important milestone in our commitment to expand the clinical utility of our sepsis test panels and we look forward to working through the premarket review process to obtain clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “Candidiasis disproportionally affects critically ill children, and we believe a pediatric testing claim for our FDA-cleared T2Candida Panel will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients.”