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T2 Biosystems, Inc. (NASDAQ:TTOO) shares are trading higher on Wednesday after the company submitted a 510(k) premarket notification to the U.S. Food and Drug Administration 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.
"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.
The T2Candida Panel runs on the FDA-cleared T2Dx Instrument and simultaneously detects five Candida species.
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.
"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 patient," Sperzel added.
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Price Action: TTOO shares are trading higher by 12.57% to $6.09 on the last check Wednesday.
Posted In: TTOO
