T2 Biosystems (NASDAQ:TTOO) has received FDA clearance to market its T2Candida Panel for pediatric patients, expanding its market to over 200 children's hospitals in the United States. This clearance marks a significant advancement in the rapid detection of sepsis-causing Candida species in children, potentially leading to faster diagnosis and targeted treatment.
The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood in just 3-5 hours, without waiting days for blood culture results. The 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 (CDC), these five species account for up to 95% of all Candida bloodstream infections in the U.S.
Faster Detection and Improved Sensitivity
Studies have demonstrated that the T2Candida Panel detects Candida species significantly faster and with greater sensitivity compared to blood culture-based diagnostics. A study published in the Journal of Clinical Microbiology (2022) conducted at the Bambino Gesù hospital in Rome, Italy, found that pediatric patients suspected of fungal bloodstream infections who 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, identifying six additional probable or possible fungal bloodstream infections in pediatric patients that were missed by blood culture.
Clinical Impact and Cost Savings
According to the Journal of Fungi, Candida species are a major contributor to morbidity and mortality in hospitalized children. 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 per case. The T2Candida Panel's rapid detection capabilities can lead to earlier targeted antifungal therapy, potentially reducing hospital stays and costs.
Expert Commentary
"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 U.S.," stated John Sperzel, Chairman and CEO of T2 Biosystems. "Studies show that the T2Candida Panel detects Candida species significantly faster, and with greater sensitivity, when compared to blood culture-based diagnostics, and we believe the new pediatric testing claim will allow clinicians to improve outcomes and reduce cost by achieving faster targeted antifungal treatment for their pediatric patients."
High Sensitivity and Specificity
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. The T2Candida Panel was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.
Future Prospects
T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme Panel, and the expanded T2Candida Panel to add the detection of Candida auris.
