The LymeX Diagnostics Prize is a competition to accelerate the development of Lyme disease diagnostics. The $1 million Phase 1 calls on scientific, technical, and clinical experts to submit innovative methods for detecting active Lyme disease infections in people. The ultimate goal of the multiphase competition is to nurture the development of these diagnostics toward Food and Drug Administration review. The competition anticipates awarding up to $10 million in prizes across all potential phases, subject to availability of funds.

The problem

Lyme disease is the most common vector-borne disease in the United States. An estimated 476,000 Americans are diagnosed and treated for Lyme disease each year — but the true number of infections is unknown. Lyme disease symptoms vary from patient to patient, and early diagnosis is critical. Unlike many other infectious diseases, there are no reliable tests for directly detecting the presence of the uniquely complex Lyme-disease-causing bacteria.

Despite the progress made in deepening our understanding of Lyme disease’s microbiological origins, there have been no major breakthroughs in Lyme disease diagnostics over the past 25 years. Current approaches can result in incorrect or missed diagnoses, particularly early in the acute stage when available treatments are most effective. As the geographic range of ticks, mosquitoes, and fleas that can transmit pathogens and cause disease expands within the United States, the need for diagnostic innovation will only become more urgent.

The opportunity

Better diagnostics yield better information, which yields better decisions and responses. If we can measure a problem and understand how big it is, we’re one step closer to solving it. Recent advances in diagnostic and other technologies offer unique potential to solve the wicked problem of detecting Lyme-disease-causing bacteria. Translating these advances into actual diagnostic tests requires ideation, development, validation, approval, and market implementation, enabled by progressive levels of funding. Promising approaches and technologies include identification of new biomarkers, imaging techniques, emerging genomic technologies, and other approaches yet to be identified. With the LymeX Diagnostics Prize, U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation (“Cohen Foundation”) intend to speed development of the next generation of Lyme disease diagnostics while sparking sustained innovation, participation, and capital investment.

The LymeX Diagnostics Prize will help entrants overcome diagnostic development barriers, providing funding and technical assistance while fostering cross-disciplinary collaboration and partnerships. Through the competition, successful diagnostic tests will move toward FDA submission with a greater level of maturity, sensitivity, specificity, and potential for patient impact than would otherwise be possible.

About LymeX

The LymeX Diagnostics Prize is sponsored by the Lyme Innovation Accelerator (LymeX), a partnership between HHS and the Cohen Foundation. LymeX is the world’s largest public-private partnership for Lyme disease, fostering collaborative innovation among patients and advocates, academia, nonprofits, industry, and government. As a component of a larger moonshot, LymeX is identifying, developing, and implementing advancements in Lyme disease care. In addition to accelerating next-generation diagnostics, LymeX is spearheading development of human-centered solutions and fostering breakthroughs in education and awareness. Learn more about Lyme disease and LymeX’s work to date.

Competition overview

With the LymeX Diagnostics Prize, HHS and the Cohen Foundation hope to bridge the gap between promising diagnostic concepts and sensitive, specific solutions. Specifically, this multiphase prize competition seeks to accelerate solutions that will accurately diagnose an active infection of Lyme disease and will be submitted to the FDA for review and clearance.

Phase 1: Concepts and plans for development

The first phase of the competition calls on all eligible entrants — including scientific, technical, and clinical experts — to submit detailed concepts and plans for development.

  • Each entrant will submit a concept paper that describes their proposed solution and their scientifically rigorous rationale for success. The submission should include an ambitious but achievable roadmap for prototyping, iterating, testing/validating, and evaluating.
  • The proposed solutions must accurately diagnose an active infection of Lyme disease, benefitting patients and clinicians. Entrants should indicate their pathway toward eventual FDA review and clearance.
  • A judging panel will evaluate eligible submissions according to official Phase 1 evaluation criteria. Based on this evaluation, the panel will recommend up to 10 Phase 1 winners, who will receive an equal share of the $1 million Phase 1 prize pool and will be exclusively invited to participate in a planned Phase 2.
  • All submissions must be completed using the Phase 1 submission form and submitted by 4:59 p.m. EDT on August 8, 2022.
  • As part of their submissions, Phase 1 entrants agree to have brief synopses or abstracts of their submissions published by LymeX.

Phase 2: Development and prototyping

Phase 2 details will be confirmed and announced prior to the beginning of the phase. LymeX anticipates the planned second phase will invite Phase 1 winners to prototype and refine their solutions with additional validation data and clinical protocol development. Other Phase 2 details may include:

  • Phase 1 winners will be exclusively eligible to compete for the anticipated prize pool of $2 million (subject to availability of funds).
  • Up to five Phase 2 winners may be selected to receive a share of the anticipated prize pool and advance to a potential Phase 3 if launched.
  • The Competition will provide technical assistance to help teams accelerate and prototype their solutions.
  • Phase 2 is anticipated to begin by late 2022.

Future phases

At the discretion of HHS and the Cohen Foundation, and subject to availability of future funding, at least one additional phase may follow Phase 2. Future phases are expected to focus on clinical and nonclinical validation of diagnostic test(s) that detect active infection by Lyme-disease-causing bacteria, as well as readiness for regulatory submission and market entry. Over $7 million in additional prizes are projected to be available to future phases.

Note: No future phases or prizes are guaranteed beyond Phase 1. Future phases may be launched at the discretion of HHS and Cohen Foundation, and any prize amounts beyond Phase 1 are anticipated and subject to future availability of funds.