T2 Biosystems | MedPath

T2 Biosystems' T2Candida Panel Receives FDA Clearance for Pediatric Use

8 months ago

• T2 Biosystems has received FDA clearance to market its T2Candida Panel for pediatric patients, expanding its availability to over 200 children’s hospitals in the U.S. • The T2Candida Panel detects five _Candida_ species directly from blood in 3-5 hours, significantly faster than traditional blood culture methods. • Studies show the T2Candida Panel offers greater sensitivity and faster species identification, potentially improving outcomes and reducing costs for pediatric patients with invasive candidiasis. • Clinical data indicates the T2Candida Panel can reduce the time to species identification by over 120 hours compared to blood culture, leading to quicker targeted antifungal treatment.

T2 Biosystems' T2Candida Panel Receives FDA Clearance for Pediatric Use

8 months ago

• T2 Biosystems has secured FDA clearance to market its T2Candida Panel for pediatric patients, expanding its reach to over 200 children's hospitals in the U.S. • The T2Candida Panel is the only FDA-cleared diagnostic test capable of detecting sepsis-causing Candida species directly from blood within 3-5 hours. • Clinical studies demonstrate the T2Candida Panel's superior speed and sensitivity compared to traditional blood culture methods, enabling faster, targeted antifungal treatment. • The FDA clearance allows for improved patient outcomes and reduced healthcare costs through quicker diagnosis and treatment of invasive candidiasis in children.

T2 Biosystems Advances Diagnostic Pipeline for AMR, Pediatric Infections, Lyme Disease, and Candida auris

8 months ago

• T2 Biosystems is finalizing its 510(k) application for the T2Resistance Panel, aiming for FDA submission in Q4 2024 to combat antimicrobial resistance. • The company seeks FDA clearance to expand the T2Candida Panel for pediatric Candida infections and the T2Bacteria Panel for pediatric bacterial infections. • T2 Biosystems will establish its own lab to launch the T2Lyme Panel as a Laboratory Developed Test, ensuring greater control and potential profit. • Non-dilutive funding is being pursued to advance the development of a diagnostic test for Candida auris, addressing a critical public health threat.