T2 Biosystems Announces FDA 510(k) Submission to Expand Use of the 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 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.
- 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.
- T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.