U.S. Department Of Health And Human Services And Steven And Alexandra Cohen Foundation Name T2 Biosystems A Phase 2 Winner In The LymeX Diagnostics Prize, T2 Biosystems Will Receive $265,000

Author: Benzinga Newsdesk | February 07, 2024 10:16am

T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that the U.S. Department of Health and Human Services ("HHS") and the Steven & Alexandra Cohen Foundation ("Cohen Foundation") have selected T2 Biosystems as a Phase 2 winner in the LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics. As a Phase 2 winner, T2 Biosystems will receive $265,000.

 

T2 Biosystems' solution, the T2Lyme™ Panel, is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2Dx® Instrument and to detect Borrelia burgdorferi, the bacteria that causes Lyme disease. The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease. T2 Biosystems has previously received Breakthrough Device Designation from the U.S. Food and Drug Administration and received a patent from the U.S. Patent and Trademark Office, both covering the T2Lyme Panel.

"We are thrilled to announce that we have been selected as a Phase 2 winner in the LymeX Diagnostics Prize," stated John Sperzel, Chairman and CEO of T2Biosystems. "We appreciate the continued leadership from HHS and the Cohen Foundation to support innovation and advance next generation Lyme diagnostics, and we are grateful to receive this support to advance our T2Lyme Panel for the detection of early Lyme disease."

There is a critical need for new Lyme disease diagnostics. With an estimated 476,000 cases annually, Lyme disease is by far the leading vector-borne disease in America. The current diagnostic process, a two-tiered antibody testing algorithm originally developed in 1994 for disease surveillance and not as a stand-alone diagnostic test, relies on the presence of antibodies and can only be used accurately four to six weeks after infection. Early diagnosis of Lyme disease is critical. If left untreated, the debilitating disease can become harder to eradicate and spread throughout the body.

From January to September 2023, 10 entities participated in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections in people. The Phase 2 virtual accelerator offered access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the cohort progress toward FDA review.

Phase 2 awarded $2 million in prizes based on the teams' interim and final submissions. Each team's final concept paper described how they are developing their diagnostic, included clinical and patient input, and proposed a roadmap from laboratory to market that includes FDA review. The competition judging panel—composed of experts in areas such as vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology—evaluated eligible submissions according to official Phase 2 evaluation criteria.

Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Steven & Alexandra Cohen Foundation, at least $7 million in additional LymeX prizes are projected to be available in proposed future phases.

Visit LymeXDiagnosticsPrize.com for more information and subscribe to the competition newsletter to receive future updates.

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