Below is a summary of the most frequently asked questions during the virtual information session on June 16, 2022.
Submissions for Phase 1 of the LymeX Diagnostics Prize closed on August 8, 2022, at 4:59 p.m. EST.

Competition scope and goals

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 request for information (RFI) and letter of intent (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.

Phase 1 criteria and evaluation

What is the Phase 1 evaluation process?

A multidisciplinary judging panel will recommend winners after evaluating submissions based on the equally weighted evaluation criteria. Depending on the volume of submissions received, an expert panel may conduct an initial review of eligible submissions and determine a subset for judge evaluation. 


In evaluating diagnostic performance metrics (for example, sensitivity, specificity), is there a preferred set of comparator methods that judges will deem appropriate (for example, Lyme Disease score methods, immunological and/or RT-PCR methods, or a combination of these)?

Because the competition seeks a range of innovative diagnostic approaches, we recognize that the approach to performance measurement and validation may differ from one concept to another; judges will take this into account when evaluating against the Phase 1 criteria. A successful submission will likely include context and credible justification for proposed performance targets, comparator methodologies, regulatory science grounding, etc., given the unique characteristics of the conceived test(s). Potential future phases will likely address further development and refinement of target performance and validation approaches, supported by technical assistance the competition anticipates offering during those phases.


For full eligibility guidelines, please carefully review the rules, terms, and conditions. 

Who is eligible to enter the LymeX Diagnostics Prize?

Pursuant to the COMPETES Act, at the time of entry, the individual entrant or team lead must be a U.S. citizen or permanent resident of the United States or its territories. In the case of a private entity, the business shall be incorporated in and maintain a place of business in the United States or its territories. 


How can I participate as a non-United States citizen? 

Non-U.S. citizens and non-permanent residents may participate as a member of a team if the team lead satisfies the eligibility criteria. To be eligible to receive a prize, the primary entrant or entity named on the team’s submission must be a U.S. citizen or permanent resident, or in the case of entities, must be headquartered in the U.S. Please note that only one prize payment will be issued to the entering individual, team lead, or primary entity named on each winning submission; any subsequent distribution of prize funds to other team members or entities is at the prize recipient’s discretion and is not the responsibility of HHS or the Steven & Alexandra Cohen Foundation.


Can federal employees enter the LymeX Diagnostics Prize?

Employees of the Department of Health and Human Services (or any other component of HHS) acting in their personal capacity are not eligible to win a prize. A federal entity or federal employee of an agency other than HHS may be eligible to win a prize if acting outside the scope of their employment, but may not work on their submission during assigned duty hours and should consult with their agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a COMPETES Act prize. Federal grantees may not use federal funds to develop submissions unless use of such funds is consistent with the purpose of their grant award; such grantees should obtain approval from the appropriate grants management or program officer prior to submitting.


I am supporting the LymeX Diagnostics Prize as a member of the review panel or the judging panel. Am I eligible to enter?

Review panelists, judges, and partners are not eligible to enter or support entrants as a team member.


I have already submitted or am planning to submit my solution to another grant or prize competition. Is it still eligible for submission to the LymeX Diagnostics Prize?

Entry to another grant or competition does not inherently impact LymeX Diagnostics Prize eligibility, although other grants and competitions may restrict the usage of funds in the event the submission is selected as a winner. Entrants should consult the rules and terms of other programs to understand if restrictions apply. 


Can solutions already developed on a federal contract or grant be submitted?

An otherwise eligible entrant or team is not ineligible because they received federal funds in the past. However, federal grantees may not use federal funds to develop their competition submissions unless use of such funds is consistent with the purpose of their grant award or cooperative agreement. Federal grantees who use federal funds to develop their competition submissions must also obtain written prior approval from the appropriate grants management or program officer.

Federal contractors may not use federal funds from a contract to develop their competition submissions or to fund efforts in support of their competition submissions.


Is it possible to wait until a future competition phase to submit my solution?

It is expected that planned future phases of the competition will only be open to winners of the preceding phase. This means that if an entrant does not submit a solution to Phase 1, they will not be able to submit a solution to a later phase or be considered for any monetary or non-monetary prizes associated with those phases.


What is the prize pool for the LymeX Diagnostics Prize?

Up to 10 winners will receive an equal share of the $1 million prize pool in Phase 1. Across potential future phases, the competition anticipates awarding up to $9 million in additional prizes, subject to availability of funds.

Note that awards will not be based on any budgets included in the submission, as this is a prize competition and not a grant. The prize is a fixed-amount cash award paid to each winning individual entrant, team lead, or lead entity.


Are prizes taxable?

Prizes may be taxable under applicable federal, state, local, and/or institutional laws, regulations, and policies; entrants are responsible for compliance with these requirements. No withholding will be assessed by the prize administrator on behalf of any entrant claiming a prize.


If we are a team, how will prize funds be distributed to team members?

Prizes awarded by HHS will be issued in a single electronic payment to the individual, team lead, or lead entity indicated on the submission. Any further distribution of funds to team members is at each team lead’s discretion and is not the responsibility of HHS or the Steven & Alexandra Cohen Foundation.


What activities can prize funds be used for?

Prize competitions, by design, do not place any restrictions on how award funds are used. Awardees are responsible for any applicable federal, state, and/or local taxes and reporting requirements related to their prize. 

Note that if entrants are using federal grant funds (consistent with the purpose of the grant award or agreement) to develop their submission, they will likely need to treat the prize as program income for the purpose of the original grant. Entrants should consult with the relevant grants management or program officer prior to submitting.

Submission requirements

What should my submission include?

Phase 1 calls for concept papers that describe the proposed test or tests in detail, give a well-supported rationale for why the test will be successful, and summarize a plan for development and validation over the next few years. Submissions should also clearly address how entrants plan to prepare for near-term submission of developed tests to FDA for review and regulatory clearance. Please view the complete submission form for detailed instructions.


What are the file and formatting requirements for the concept paper?

Submissions should be no longer than 10 pages, and should be formatted with 1-inch margins (2.5 cm), single or double-spaced, using Times New Roman font with minimum 12-point size for prose and minimum 10-point font for tables and charts. Appendices can be included but are not guaranteed review.


Can I include links in my concept paper?

Links can be included but will not be considered a description of your technical approach and are not guaranteed review by evaluators. 


Are team descriptions or references included in the 10-page limit?

References are not counted against the 10-page limit and may be included, if clearly delineated, in an appendix.


Can I review my submission after I submit it?

Once a submission has been submitted, it can be accessed but not adjusted. Entrants can save the submission as a draft and make adjustments at any time prior to the 4:59 p.m. EDT deadline on August 8. If an amendment is needed after submitting and before the deadline, email to re-open the submission for access.


Can I enter multiple submissions or participate on different teams?

The LymeX Diagnostics Prize can only accept one submission per individual or lead entrant registered on the competition platform. We have found that the most successful solvers in this type of competition focus their energy on a single, high-quality submission rather than attempting to enter multiple ideas or variations.


Do I retain intellectual property rights to concepts I submit to the LymeX Diagnostics Prize?

Entering the competition means granting HHS and the Steven & Alexandra Cohen Foundation license to reproduce, publish, post, link to, share, and display abstracts and non-proprietary submission content only. Entrants to the competition retain all other intellectual property rights in their solutions, as applicable, and will not be required to transfer intellectual property rights.


How can I join a team or find team members to collaborate on a submission? 

You are encouraged to join the entrant community to identify collaboration opportunities. Once signed up, your information will be shared with all other members of the community, and you will in turn receive regular updates to the database throughout the open submissions period.