Today, the U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation (Cohen Foundation) launched the LymeX Diagnostics Prize, a $1 million competition to accelerate the development of Lyme disease diagnostics. The ultimate goal of the competition is to advance the development of these diagnostics toward Food and Drug Administration (FDA) review. The first phase (Phase 1), posted May 17, 2022 today, calls on scientific, technical, and clinical experts to submit innovative methods for detecting active Lyme disease infections in people.
An estimated 476,000 Americans are diagnosed and treated for Lyme each year. While symptoms can vary from patient to patient, early diagnosis is critical. Left untreated, this bacterial infection can spread from the skin to joints, the heart, and the nervous system, making the disease more difficult to treat. Current FDA-cleared tests rely on the detection of antibodies, which can take weeks to develop in an infected person. Diagnostic tests that can promptly detect early active infection are urgently needed to improve patient care.
“With climate change and other factors only increasing the geographic and seasonal distribution of ticks across the United States, there is an urgent need to accelerate innovation in Lyme disease diagnostics,” said Assistant Secretary of Health Admiral Rachel L. Levine, M.D. “Through our LymeX public-private partnership, HHS and the Steven & Alexandra Cohen Foundation are driving the next major innovations in Lyme disease diagnostics testing—ones that could significantly improve outcomes for patients.”
Entrants should submit detailed concepts and plans for development of innovative detection methods by 4:59 p.m. ET on August 8, 2022. The competition seeks concept papers that describe proposed solutions and scientifically rigorous rationales for success, including ambitious but achievable roadmaps for prototyping, iteration, testing and validation, and evaluation. To learn more, entrants can join a virtual information session on Thursday, June 16, 2022.
“We are thrilled to be partnering with HHS on this competition that will bring together patients, advocates, clinicians, and innovators with broad expertise to accelerate breakthroughs in Lyme disease diagnostics,” said Steven & Alexandra Cohen Foundation President Alexandra Cohen.
The competition judging panel—composed of experts across sectors such as vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology—will evaluate eligible submissions according to official Phase 1 evaluation criteria. Based on this evaluation, the panel will recommend up to ten Phase 1 winners. HHS will select winners from the top-scoring submissions as evaluated by the judging panel. The winners will receive an equal share of the $1 million Phase 1 prize pool. If the planned Phase 2 moves forward, the winners of Phase 1 will be invited to participate in the second phase (Phase 2) of the competition.
During the planned second phase, it is expected that entrants will have access to technical assistance as they prototype and refine their solutions.
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 development, prototyping and validation of diagnostic tests, as well as readiness for regulatory submission and market entry.
The LymeX Diagnostics Prize is sponsored by the Lyme Innovation Accelerator (LymeX), a partnership between the U.S. Department of Health and Human Services and the Steven & Alexandra 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. 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. For more information, visit lymexdiagnosticsprize.org.
About the U.S. Department of Health and Human Services
HHS enhances and protects the health and well-being of all Americans. HHS fulfills that mission by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. For more information, visit hhs.gov.
About the Steven & Alexandra Cohen Foundation
The Steven & Alexandra Cohen Foundation is committed to inspiring philanthropy and community service by creating awareness, offering guidance, and leading by example to show the world what giving can do. The Foundation’s grants support nonprofit organizations based in the United States that either help people in need or solve complex problems. The Foundation is the largest private funder of Lyme and tick-borne disease research in the United States with over $75 million disbursed for groundbreaking studies in prevention, diagnostics, and treatment as well as building essential research infrastructure to catalyze innovation. The Foundation also spearheads grassroots campaigns to encourage others to give. For more information, visit steveandalex.org.