The LymeX Diagnostics Prize has launched Phase 4, inviting seven teams to execute their clinical validation plans and complete regulatory submissions to the U.S. Food and Drug Administration (FDA). The goal of the multiphase competition is to nurture the development of diagnostics toward FDA review and clearance. The LymeX Diagnostics Prize Phase 3 and Phase 4 are supported by the Steven & Alexandra Cohen Foundation through a fiscal sponsorship with Digital Harbor Foundation. The competition is made possible thanks to a more than $10 million pledge from the Steven & Alexandra Cohen Foundation.
America faces a critical need for improved Lyme disease diagnostics, with an estimated 476,000 people diagnosed and treated for Lyme disease in the U.S. each year. The current testing protocol — a two-tier antibody system from 1994 originally designed for surveillance rather than diagnosis — is only reliable four to six weeks post-infection. This significant delay prevents timely treatment, putting patients at risk of developing more serious complications.
Select teams have been invited to compete in Phase 4. These teams intend to submit novel diagnostics for active Lyme disease infection to the FDA within the competition timeline.
Meet the teams participating in Phase 4:
- BlueArc Biosciences Inc. (La Jolla, California). An ultrasensitive and specific blood test for the direct detection of B. burgdorferi infection from the first symptoms of Lyme disease using standard laboratory equipment.
- Drexel University College of Medicine (Philadelphia). A small-volume serum test using glycan biomarkers to detect active Lyme disease infection and track treatment response.
- HelixBind Inc. (Boxborough, Massachusetts). A direct-from-blood molecular assay that can detect DNA from intact Borrelia spirochetes utilizing a proprietary, readily automated sample-to-answer process.
- Galaxy Diagnostics (Research Triangle Park, North Carolina). A high-sensitivity direct antigen detection test that identifies Borrelia proteins in urine samples for diagnosing active and chronic Lyme disease.
- Northwestern University, Feinberg School of Medicine, led by Jutras Lab, formerly at Virginia Tech. (Chicago). A test using monoclonal antibodies in conjunction with both immuno-PCR and lateral flow to rapidly detect a unique B. burgdorferi biomarker in blood and urine.
- Massachusetts General Hospital (Boston). A plasma and extracellular fluid test depleting human background material from samples and detecting low-abundance nucleic acid from tick-borne pathogens.
- GNOMX Corp (New York). A high-sensitivity epigenetic blood test that detects host-response markers to identify active Lyme disease infections.
Phase 4 teams to receive technical support
The LymeX Diagnostics Prize is helping the Phase 4 teams overcome diagnostic development barriers by providing funding and technical assistance while fostering cross-disciplinary collaboration and partnerships.
This technical assistance, which will support teams’ solution development toward FDA submission, includes:
- Expert guidance on regulatory strategy, clinical study design and implementation, and manufacturing processes.
- Mentorship from subject matter experts in diagnostic development and validation.
- Networking opportunities with industry partners, including clinical laboratories, which may provide expertise in diagnostic commercialization.
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.
Entrants plan for FDA submission by 2027 in $3 million Phase 4
Phase 4 invites seven teams to execute their clinical validation plans and complete regulatory submissions to the FDA. Each team that submits a regulatory package to the FDA that is accepted for substantive review will be eligible for a $200,000 milestone prize. To qualify, a team must also show its diagnostic test meets the minimum requirements of the target product profile. These milestone prizes are available through March 28, 2027.
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 FDA Acknowledgement Letters confirming the agency’s receipt of the regulatory packages. 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.
Phase 4 teams eligible for up to $3 million in additional FDA clearance prizes
Following Phase 4, the competition anticipates awarding FDA clearance prizes, with up to $3 million available for teams that submit their FDA decision summaries indicating affirmative 510(k) Substantial Equivalence determinations or grants of De Novo Classification Request. The first and second teams to gain regulatory clearance will be awarded first place and second place, respectively. Up to five runner-up prizes may be awarded to other Phase 4 teams that gain FDA clearance. The total prize purse for FDA clearance prizes is $3 million.
Follow the teams through Phase 4: To receive all competition updates, subscribe to the LymeX Diagnostics Prize newsletter.