T2 Biosystems announced FDA clearance to market its T2Candida Panel for pediatric patients on September 16, 2024. The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood in 3-5 hours, without waiting for blood culture results. The panel detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S.Clinical studies demonstrate significant advantages of the T2Candida Panel in pediatric applications. A 2022 study at Bambino Gesù hospital showed results 121.8 hours faster than blood culture, with higher detection rates. Additionally, a prospective study in Clinical Infectious Diseases found the T2Candida Panel had the highest sensitivity and specificity among four pre-blood culture tests.The expansion allows immediate marketing to over 200 children's hospitals in the U.S., addressing a critical healthcare need. According to research, children with invasive candidiasis face extended hospital stays averaging 21 days and approximately $92,000 in excess hospital costs. The panel is expected to improve outcomes through faster targeted antifungal treatment for pediatric patients.

T2 Biosystems announced FDA clearance to market its T2Candida Panel for pediatric patients on September 16, 2024. The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood in 3-5 hours, without waiting for blood culture results. The panel detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S.Clinical studies demonstrate significant advantages of the T2Candida Panel in pediatric applications. A 2022 study at Bambino Gesù hospital showed results 121.8 hours faster than blood culture, with higher detection rates. Additionally, a prospective study in Clinical Infectious Diseases found the T2Candida Panel had the highest sensitivity and specificity among four pre-blood culture tests.The expansion allows immediate marketing to over 200 children's hospitals in the U.S., addressing a critical healthcare need. According to research, children with invasive candidiasis face extended hospital stays averaging 21 days and approximately $92,000 in excess hospital costs. The panel is expected to improve outcomes through faster targeted antifungal treatment for pediatric patients.