NEW YORK – T2 Biosystems announced Monday that its direct-from-blood diagnostic test for Candida has been granted clearance from the US Food and Drug Administration for use in pediatric patients.
The firm submitted the expanded claim in January. It increases the available market for the Lexington, Massachusetts-based diagnostic maker, T2 said in a statement.
"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 US," John Sperzel, chairman and CEO of T2 Biosystems, said in a statement.
The T2Candida diagnostic panel runs on the firm's T2Dx instrument. Using a combination of DNA amplification and magnetic resonance technology, it detects five Candida species in three to five hours directly from blood, rather than from positive blood cultures.
Specifically, it detects Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. These five species account for as many as 95 percent of sepsis cases caused by Candida in the US, according to the US Centers for Disease Control and Prevention.
Invasive candidiasis increases kids' hospital length of stay by three weeks and adds $92,000 in excess hospital costs, according to one study. Other studies have shown that the T2 test could improve the time to species identification by approximately 122 hours compared to methods that rely on blood culture, that it can detect additional cases, and that it was superior to four other direct-from-blood assays.