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T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today 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 T2Candida 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 albicans, 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.
According to the Journal of Fungi, a peer-reviewed scientific journal that provides an advanced forum for studies related to pathogenic fungi, Candida species are a major contributor to morbidity and mortality in hospitalized children. 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.
"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."
A Journal of Clinical Microbiology (2022) study conducted at the Bambino Gesù 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.
Posted In: TTOO
