Lexington, MA-based T2 Biosystems has received clearance from the U.S. Food and Drug Administration (FDA) to market its T2Candida Panel blood test for pediatric patients.
The test works through a combination of DNA amplification and magnetic resonance imaging on T2's benchtop multiplex instrument. The T2Candida Panel is designed to detect sepsis-causing Candida species, including C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C. glabrata, directly from blood, within three to five hours, according to the company.
T2 Biosystems noted that these five species account for 95% of all Candida bloodstream infections. The company's expanded pediatric claim could increase use of the blood test in children's hospitals around the U.S. The company also cited a data point that Candida contributes to a mean increased hospital length of stay of 21 days and approximately $92,000 in excess hospital costs.
