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HHS, Steven & Alexandra Cohen Foundation Award $2M to Lyme Disease Dx Projects

NEW YORK – The US Department of Health and Human Services and the Steven & Alexandra Cohen Foundation announced on Wednesday the five Phase 2 winners of its LymeX Diagnostics Prize. 

The winners are BlueArc Biosciences, Drexel University, HelixBind, T2 Biosystems, and Virginia Tech. Each will be awarded $265,000.

In 2023, 10 teams participated in a virtual accelerator that was designed to help them refine their concepts for detecting active Lyme disease infections in people, HHS and the Cohen Foundation said in a statement. The accelerator offered access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities intended to help the cohort move toward US Food and Drug Administration review. 

BlueArc Biosciences has developed a PCR-based blood test for Lyme Borrelia burgdorferi s.l., and Virginia Tech created a test that uses monoclonal antibodies combined with immuno-PCR and lateral flow to detect a unique B. burgdorferi biomarker in blood and urine. HelixBind is working on an automated test to detect and identify active Lyme borreliosis directly from blood in three hours, while T2 Biosystems developed a whole-blood test to directly detect Lyme disease-causing bacteria in three to five hours. The Drexel University team created a small-volume serum test that uses glycan biomarkers to detect active Lyme disease infection and track treatment response.

T2 Biosystems' T2Lyme Panel previously received breakthrough device designation from the FDA. 

Each team's final concept paper described how they're developing their diagnostic and proposed a roadmap from laboratory to market that includes FDA review, HHS and the Cohen Foundation said. The competition judging panel included experts in vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology.

An additional $7 million in additional LymeX prizes are expected to be available in proposed future phases, HHS and the Cohen Foundation noted. In 2022, 10 groups were awarded $1 million for Lyme disease diagnostics, including HelixBind, T2 Biosystems, Drexel University, Virginia Tech, and BlueArc Biosciences.

"With Lyme disease cases approaching an estimated 500,000 annually, Americans need an FDA-approved diagnostic that can accurately test for active infections," Michael Iademarco, deputy assistant secretary for science and medicine, said in a statement. "HHS is working with the Steven & Alexandra Cohen Foundation through the LymeX Innovation Accelerator public-private partnership to accelerate crucial innovations in industry and academia that could improve treatment and care for this debilitating disease."