T2 Biosystems Submits 510(k) to FDA to Expand Use of Candida Panel

Original from: 360dx

Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing. 

The test is FDA cleared and simultaneously detects five Candida species — Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata — directly from blood in three to five hours, the Lexington, Massachusetts-based company said in a statement. The assay runs on the firm's T2Dx instrument.

"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," T2 Chairman and CEO John Sperzel said in a statement. "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 study published in the Journal of Clinical Microbiology in 2022 found that pediatric patients with suspected fungal bloodstream infections received species identification results 121.8 hours faster with T2Candida than with blood culture, the company noted.

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Source: T2 Biosystems Submits 510(k) to FDA to Expand Use of Candida Panel