T2 Biosystems, Inc. is a vitro diagnostics company, which engages in the development of detection of sepsis-causing pathogens. It offers T2Dx instrument, T2Bacteria, T2Candida, T2Biothreat panels, and T2MR technology. The company was founded by Michael J. Cima, Robert S. Langer Jr., Tyler Jacks, Lee Josephson, W. David Lee, and Ralph Weissleder on April 27, 2006 and is headquartered in Lexington, MA.
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- DelveInsight's 2025 pipeline report identifies 7+ companies developing novel Lyme disease therapies, with emerging treatments including BLB 400, FP-100, CT38, TP-05, and VLA15 expected to significantly impact the market. - Valneva and Pfizer reported positive Phase II booster results for their Lyme disease vaccine candidate VLA15 in September 2024, following completion of the primary vaccination series for their Phase III VALOR trial in July 2024. - Tarsus Pharmaceuticals announced encouraging results from their Phase IIa "Tick-Kill" trial of TP-05 (lotilaner) for Lyme disease prevention in February 2024. - The pipeline spans multiple development stages from preclinical to Phase III, with various routes of administration including oral, parenteral, intravenous, subcutaneous, and topical formulations.
- 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 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 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.
