What is the primary focus of the competition?
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 next-generation 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. Learn more about the prize competition.
How did prior RFI and LOI responses to LymeX inform the LymeX Diagnostics Prize?
RFI and LOI responses informed prize design. A submission of an LOI or response to the RFI are not required to participate in Phase 1. Participation in the RFI and/or LOI do not constitute a Phase 1 submission and will have no bearing on the Phase 1 evaluation process.
Is my _____ test in the scope of the competition?
The LymeX Diagnostics Prize intentionally does not prescribe a particular approach. Entrants are encouraged to submit a wide range of technologies, analytes, sample types, etc., in order to accelerate a diverse set of promising concepts in the next competition phase and beyond.
What matters is that entrants demonstrate how their concepts meet the goal of the competition — developing next-generation diagnostics that can accurately detect active Lyme disease infections in people — and address all the requirements noted in the submission form, demonstrating how the concept delivers on the evaluation criteria previously referenced.
Out of fairness to all potential entrants, we are not able to address inquiries about specific concepts or proposals.
Is the LymeX Diagnostics Prize seeking one particular type of diagnostic test — for example, lab-developed, point of care, at-home?
The prize competition is open to a wide range of diagnostic approaches, provided they meet the competition goals and criteria. The equally weighted evaluation criteria balance multiple considerations including performance of the test(s), technical maturity, viability and sustainability of future development, and potential for clinical and patient impact.
We anticipate many of the concepts that meet the stated goals and criteria will be point-of-care tests, but entrants are encouraged to submit all concepts they believe meet the goals and criteria of the competition, regardless of setting or use case.
Note that successful submissions will also show a clear and credible pathway to FDA review and clearance — not merely lab-developed tests operating under a Clinical Laboratory Improvement Amendments (CLIA) waiver or other certification. FDA review assesses the clinical validity and performance of tests in a way that the CLIA system does not. This is crucial to future scaling and accessibility of tests developed. For more information, see this PDF overview of the CLIA program and Laboratory Developed Tests (LDTs).
What level of fidelity does the LymeX Diagnostics Prize expect? What if my solution is currently a concept? What if my solution is already validated with a path to FDA submission?
Successful Phase 1 submissions do not necessarily need to be an existing test or market-ready solution. The competition hopes to accelerate highly innovative concepts that transform Lyme disease diagnostics. Phase 1 seeks detailed concepts and plans for development that address how entrants plan to further develop their test(s) and prepare for regulatory submission.
Entrants are also encouraged to submit if they believe their solution exceeds certain expectations of Phase 1 submissions. Potential future phases of the competition, if launched, may provide significant additional monetary prizes as well as non-monetary resources (for example, technical assistance, access to mentors) to develop tests further, validate, and prepare for market entry and commercialization.