Phase 1 winners will receive resources and mentorship to nurture development of diagnostics toward FDA review.

Each year, an estimated 476,000 Americans are diagnosed and treated for Lyme disease, but the true number of infections is unknown — partly because there is currently no FDA-cleared test for active Lyme disease infection. Meanwhile, the geographic range of Lyme disease risk is expanding. The chances of encountering tick bites and Lyme disease are increasing, but current diagnostics miss up to 60% of early-stage cases.

There’s a critical need for diagnostics innovation. But it’s a difficult problem to solve, and innovators need resources and support to overcome barriers to development. By using a prize competition, rather than relying on traditional grantmaking, the LymeX Diagnostics Prize offers cash prizes alongside a range of non-monetary resources. The competition, designed and produced by Luminary Labs, is stimulating the market for Lyme disease diagnostics by bringing together a diverse group of experts to address an unmet societal need. Phase 1 of the LymeX Diagnostics Prize inspired 52 teams to submit innovative concepts. After judges evaluated submissions, HHS awarded $1 million to 10 winning teams ($100,000 to each team) in a highly competitive field.

This month, the U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation launched Phase 2 of the LymeX Diagnostics Prize, inviting the 10 Phase 1 winners to participate in a virtual accelerator. Through September 2023, the accelerator cohort will refine their concepts for detecting active Lyme disease infections in people. The goal of the multiphase LymeX Innovation Accelerator (LymeX) competition is to nurture the development of Lyme disease diagnostics toward Food and Drug Administration review.

The LymeX Diagnostics Prize Virtual Accelerator offers the cohort access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review. A selection of accelerator resources will be made available to the public on the competition website to support broader innovation in Lyme disease diagnostics and treatment. These public resources continue LymeX engagement with the community, enabling information exchange and shared learning.

Following the accelerator, the cohort will submit concept papers that detail solution refinement, clinical and patient input, and a roadmap from lab to market. The cohort will also participate in a presentation and Q&A session with judges. The competition judging panel — composed of experts across sectors such as biology, clinical and technology translation, patient experience and advocacy, diagnostic science and technology, exponential innovation, and ethics — will evaluate eligible submissions according to official Phase 2 evaluation criteria. Based on the judges’ evaluations, the panel will recommend up to five Phase 2 winners of the LymeX Diagnostics Prize.

Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Steven & Alexandra Cohen Foundation, $9 million in LymeX prizes are projected to be available in proposed future phases. Phase 2 is part of this multiyear, multiphase LymeX Diagnostics Prize series; HHS plans to announce further details in early 2023.