T2 Biosystems Wins Phase 2 LymeX Diagnostics Prize

T2 Biosystems, a company at the forefront of swiftly identifying pathogens responsible for sepsis and genes resistant to antibiotics, has been recognized as a Phase 2 winner in the LymeX Diagnostics Prize. This accolade came from the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation, which are driving a competition aimed at speeding up the development of diagnostic tools for Lyme disease. As a result of this achievement, T2 Biosystems is set to receive a financial boost of $265,000.

The company's proposed solution is the T2Lyme™ Panel, a molecular diagnostic test that can be conducted directly from blood samples. This test is designed to be used on the FDA-approved T2Dx® Instrument and is capable of detecting Borrelia burgdorferi, the bacterium that triggers Lyme disease. The test is intended for individuals exhibiting signs and symptoms of the disease, with the goal of facilitating the diagnosis of its early stages. T2 Biosystems has already been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration and has also secured a patent from the U.S. Patent and Trademark Office for the T2Lyme Panel.

John Sperzel, the Chairman and CEO of T2 Biosystems, expressed his enthusiasm about the Phase 2 win and acknowledged the support from HHS and the Cohen Foundation in fostering innovation for the next generation of Lyme disease diagnostics. He also expressed gratitude for the financial support that will aid in advancing the T2Lyme Panel for early Lyme disease detection.

Lyme disease is a significant public health concern, with an estimated 476,000 cases occurring each year, making it the most prevalent vector-borne disease in the United States. The current diagnostic methods, which were established in 1994 for disease surveillance rather than as a diagnostic test, rely on the detection of antibodies and are only accurate four to six weeks post-infection. Early and accurate diagnosis is crucial, as untreated Lyme disease can become more challenging to treat and can spread throughout the body.

Between January and September 2023, ten entities took part in a virtual accelerator program aimed at refining their approaches to detecting active Lyme disease infections. The Phase 2 virtual accelerator provided participants with virtual learning opportunities, mentorship, subject matter expertise in biorepository, and networking opportunities to help them progress toward FDA review.

Phase 2 of the competition awarded $2 million in prizes, contingent on the teams' interim and final submissions. The final concept papers from each team detailed their diagnostic development process, incorporated clinical and patient feedback, and outlined a plan from lab to market, including FDA review. The competition's judging panel, composed of experts in vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology, evaluated the submissions based on the official Phase 2 evaluation criteria.

The LymeX Diagnostics Prize has received a 10 million commitment from the Steven & Alexandra Cohen Foundation, which suggests that at least 7 million in additional prizes will be available in future phases of the competition.

Lyme disease is a bacterial infection transmitted to humans through the bite of infected ticks, predominantly caused by the Borrelia bacteria. It is the most common vector-borne illness in the United States, with the Borrelia burgdorferi bacterium spread by deer ticks in specific regions of the country. The U.S. Centers for Disease Control and Prevention estimates that approximately 476,000 Americans may contract Lyme disease each year. Typical symptoms include fever, headache, fatigue, and a skin rash known as erythema migrans. If untreated, the infection can spread to joints, the heart, and the nervous system.

T2 Biosystems is dedicated to improving patient care by rapidly detecting bacterial and fungal pathogens, enabling quicker targeted antimicrobial treatment. The company's products, powered by T2 Magnetic Resonance technology, include a range of diagnostic panels and instruments. T2 Biosystems also has a pipeline of future products in development.