T2 Biosystems, Inc. announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the use of its FDA-cleared T2Candida Panel to include pediatric testing. The T2 Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture. The T2Candida Panel runs on the FDA-cleared T2Dx Instrument and simultaneously detects five Candida species - including Candida albican, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.

According to the U.S. Centers for Disease Control and Prevention, up to 95% of all invasive Candida infections in the U.S. are caused by the five Candida species detected by the T2Candida Panel. Additionally, children with invasive candidiasis present a significant burden to the U.S. healthcare system, with a mean increased hospital length of stay of 21 days and approximately $92,000 in excess hospital costs. A Journal of Clinical Microbiology(2022) study conducted at the Bambino Gesu hospital in Rome, Italy found that pediatric patients suspected of fungal bloodstream infections that were tested with the T2Candida Panel received species identification results 121.8 hours faster compared to blood culture.

The study also found a higher detection rate with the T2Candida Panel as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by the T2Candida Panel and missed by blood culture. In addition, a prospective observational study published in Clinical Infectious Diseases (2022) evaluated the performance of four pre-blood culture tests for detecting the presence of invasive candidiasis in pediatric patients and found that the T2Candida Panel had the highest sensitivity and specificity of all four assays among five hundred patients enrolled. T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.