Each year in the United States, nearly half a million people are diagnosed with Lyme disease, but the true number of infections is unknown. The current diagnostic process is limited; it relies on a characteristic bulls-eye skin rash called erythema migrans or the CDC-recommended two-tier antibody testing system — which was originally developed in 1994 for disease surveillance, not as a stand-alone diagnostic test, and can only be used accurately four to six weeks after infection.

There is currently no FDA-cleared test for active Lyme disease infection. Early diagnosis of Lyme disease is critical. If left untreated, the debilitating disease can become harder to eradicate and spread throughout the body. Better diagnostics yield better information, which will yield better decisions and responses. Our understanding of current prevalence relies on reported cases, but active surveillance requires active data.

Scientists have described the genome of Lyme disease-causing spirochetes as the most complex of all bacteria, and developing direct diagnostic tests is extremely difficult. Recent advances in diagnostic and other technologies hold great potential for new solutions, but innovators need a range of resources and support — from monetary incentives to learning opportunities — to overcome barriers.

Building the infrastructure for health innovation requires balancing the right approaches, the right partners, and the right funding mechanisms to help diagnostic solutions advance from concepts to clinical studies to market-ready products. To foster breakthrough diagnostic innovation, Luminary Labs designed a multiyear, multiphase, multimillion-dollar competition to engage stakeholders around a shared purpose and an opportunity to stimulate the market.

Luminary Labs worked with the Lyme Innovation Accelerator (LymeX), a public-private partnership between the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation, to conduct a market analysis in 2021 and launch the LymeX Diagnostics Prize in 2022. The competition is accelerating the development of Lyme disease diagnostics and nurturing solutions toward Food and Drug Administration review. Now, Phase 3 and Phase 4 of the LymeX Diagnostics Prize are sponsored by the Steven & Alexandra Cohen Foundation — through a fiscal sponsorship with the Digital Harbor Foundation — and supported by major industry players.

Initial research revealed distinct gaps holding back much-needed progress. In addition to funding, innovators need access to biobank samples, regulatory guidance and expertise, connections to testing facilities, and other expert support. Luminary Labs designed each phase of the competition to provide resources that can close these gaps and help solutions advance toward viability. This required convening power — and we leveraged years of experience and network-building in health and science to coalesce a community of academic researchers, entrepreneurial innovators, regulatory experts, corporate partners, patient advocacy groups, government champions, and philanthropic supporters. With a clearly defined problem and an inspiring goal, we quickly built domain expertise and engaged the community to help us define product needs and outline a path toward market-readiness.

After an initial open submissions period, Phase 2 invited 10 Phase 1 winners to participate in a virtual accelerator offering access to biorepository subject matter expertise, as well as webinars on commercialization and regulatory processes. Following the accelerator, the cohort submitted concept papers that detailed solution refinement, clinical and patient input, and a roadmap from lab to market.

During Phase 3, six teams have been planning clinical performance studies for validating their proposed solutions. In August, the LymeX Diagnostics Prize announced both Labcorp and Quest Diagnostics as industry supporters. Labcorp and Quest Diagnostics have provided non-financial in-kind support, helping Phase 3 teams deepen their understanding of the diagnostics industry, how clinical laboratories operate, and how to work with commercial laboratories. Phase 3 teams also had the opportunity to visit both Labcorp and Quest Diagnostics facilities to learn more about the clinical laboratory environment and their workflows, materials, and instrumentation. At a virtual Industry Day event hosted by Labcorp and Quest Diagnostics, Phase 3 teams learned from clinical laboratory subject matter experts through presentations and small group discussions. The sessions focused on the companies’ approaches to Lyme disease diagnostics and practical, technical, and commercial considerations for providing patient access to novel diagnostics through their clinical laboratories. At the end of Phase 3, the six Phase 3 teams presented their diagnostic concepts during a November 2024 Demo Day at Mount Sinai’s Leon and Norma Hess Center for Science and Medicine.

In Phase 4, invited teams will execute their clinical validation plans, and complete regulatory submissions to the FDA. This phase will award up to $3 million in prizes. The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation.