About the competition

The LymeX Diagnostics Prize is a competition to accelerate the development of Lyme disease diagnostics. The ultimate goal of the multiphase competition is to nurture the development of these diagnostics toward Food and Drug Administration clearance.

Phase 1 called on scientific, technical, and clinical experts to submit innovative methods for detecting active Lyme disease infections in people. Phase 2 invited the 10 Phase 1 winners to participate in a virtual accelerator that offered the cohort access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the teams progress toward FDA review. In Phase 3, six teams received technical assistance and planned clinical performance studies toward validating their proposed solutions.

In Phase 4, invited teams will receive technical assistance to execute their clinical performance studies and submit their diagnostics for FDA clearance.

The LymeX Diagnostics Prize is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation.

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 are 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, the Steven & Alexandra Cohen Foundation intends to speed development of the next generation of Lyme disease diagnostics while sparking sustained innovation, participation, and capital investment. 

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

About LymeX

The Lyme Innovation Accelerator (LymeX), a partnership between HHS and the Steven & Alexandra Cohen Foundation, launched the LymeX Diagnostics Prize in 2022. 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 the development of human-centered solutions and fostering breakthroughs in education and awareness. Phase 3 and Phase 4 of the LymeX Diagnostics Prize are sponsored by the Steven & Alexandra Cohen Foundation. Learn more about Lyme disease and LymeX’s work to date.

Competition overview

With the LymeX Diagnostics Prize, the Steven & Alexandra Cohen Foundation hopes to bridge the gap between promising diagnostic concepts and sensitive, specific solutions. The multiphase 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 called on all eligible entrants—including scientific, technical, and clinical experts—to submit detailed concepts and plans for development.

  • Each entrant submitted a concept paper that described their proposed solution and their scientifically rigorous rationale for success. The submission included 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 have indicated their pathway toward eventual FDA review and clearance.
  • A judging panel evaluated eligible submissions according to official Phase 1 evaluation criteria. Based on this evaluation, the panel recommended up to 10 Phase 1 winners, who received an equal share of the $1 million Phase 1 prize pool and were exclusively invited to participate in Phase 2.
  • All submissions were required to be completed using the Phase 1 submission form and submitted by August 8, 2022.
  • As part of their submissions, Phase 1 entrants agreed to have brief synopses or abstracts of their submissions published by LymeX.

Phase 2: Development and prototyping

Phase 2 exclusively invited all Phase 1 winners to accelerate the development of their innovative diagnostics. Phase 2 entrants refined the detailed concepts and plans for development they submitted in Phase 1, advancing the scientific and technical maturity of their proposed solutions and accelerating progress toward anticipated regulatory submissions and market entries.

  • Each Phase 2 entrant received technical assistance from mentors and subject matter experts in a virtual accelerator program.
  • The accelerator addressed a range of topics spanning scientific, technical, design, planning, clinical, and patient considerations.
  • Phase 2 entrants were invited to submit a final Phase 2 submission no later than October 9, 2023.
  • Submissions detailed the refined concept, progress made in Phase 2, prototyping and/or study outcomes, progress in addressing clinical and patient needs, updated development plans, and proposed pathway to FDA regulatory review and clearance.
  • Technical assistance materials (e.g., white papers, webinar recordings, and presentations) developed during the virtual accelerator were made available to all Phase 2 teams. The LymeX Diagnostics Prize publicly shared a selection of materials on the News page.
  • A judging panel evaluated eligible submissions according to official Phase 2 evaluation criteria. Based on this evaluation, the panel recommended 5 Phase 2 winners, who received prizes of $265,000 each. Nine teams were also awarded prizes of $75,000 each based on judges’ evaluations of interim submissions.

Phase 3: Clinical startup

Phase 3 invited six teams to enter and plan clinical performance studies to validate their proposed solutions. 

  • Each Phase 3 entrant received access to technical assistance that offered webinar modules, mentorship, and networking opportunities. 
  • Technical assistance addressed topics such as regulatory planning, clinical study design and implementation, clinician and patient considerations, manufacturing processes, and commercial development.
  • Each Phase 3 entrant had the opportunity to showcase their diagnostic test at a Demo Day event to representatives from government, industry, clinics, and consumer organizations.
  • Phase 3 entrants submitted a concept paper detailing the FDA engagement undertaken and implementation of feedback received, new or improved analytical performance data, final clinical performance study protocol, and progress achieved in planning and initiating this clinical performance study.
  • A judging panel evaluated eligible submissions according to official Phase 3 evaluation criteria. Based on this evaluation and judges’ recommendations, five prizes were awarded from a total Phase 3 prize pool of $2.1 million.

Phase 4: Regulatory submission

Phase 4 invites seven teams to execute their clinical validation plans and complete regulatory submissions to the FDA. These teams aim to submit novel diagnostics for active Lyme disease infection to the FDA within the competition timeline.

  • Teams invited to Phase 4 demonstrated their ability to meet the phase’s objectives; participation in previous phases was not required.
  • Teams will receive extensive technical support to advance their diagnostics toward FDA submission, including:
    • Regulatory strategy and clinical validation: Expert guidance on regulatory pathways, clinical study design and implementation, and manufacturing processes.
    • Mentorship: Direct engagement with subject matter experts in diagnostic development and validation.
    • Industry connections: Networking opportunities with industry partners such as clinical laboratories to support commercialization.
    • Ongoing support: Regular check-ins and needs assessments to track progress toward FDA submission.
  • Phase 4 will award up to $3 million in prizes, including milestone prizes and evaluation prizes. By January 29, 2027, teams will submit final summary papers detailing their device descriptions, final diagnostic performance data and analysis, and commercialization plans, as well as an FDA Acknowledgement Letters confirming the agency’s receipt of the 510(k) Premarket Notifications or De Novo classification requests. A judging panel will evaluate summary papers based on the official Phase 4 evaluation criteria. Based on this evaluation, the panel will recommend up to three winners who will share up to $1.6 million in prizes. Through March 28, 2027, each team that submits a regulatory package to the FDA for review will also be eligible for a $200,000 milestone prize.

FDA clearance

Following Phase 4, the competition anticipates awarding FDA clearance prizes, with up to $3 million in total prizes available for Phase 4 teams that submit their FDA decision summaries indicating affirmative 510(k) Substantial Equivalence determinations or grants of De Novo Classification Request.

Note: Future phases and any prize amounts are subject to future availability and approval of funds by the Steven & Alexandra Cohen Foundation.