Below is a summary of the most frequently asked questions during the virtual information session on December 7, 2023. These FAQs and the session recording are intended for informational purposes only and all information presented here is superseded by the challenge rules, terms and conditions.

Submissions for Phase 1 of the Lead Detect Prize closed on January 22, 2024, at 5:00 p.m. ET.

For additional inquiries, please contact hello@LeadDetectPrize.com.

Eligibility

Are international entities eligible?

Yes, any individual, team or entity that meets all eligibility requirements specified in the challenge rules, terms, and conditions is eligible to apply, including entities that are registered or incorporated outside of the United States. Entrants are not eligible to receive any monetary or non-monetary prize in the challenge if they are a person or entity designated or sanctioned by the United States Treasury’s Office of Foreign Assets Control.

Are teams able to be composed of individuals from more than one entity?

Yes, teams may include individuals from more than one entity, a single entity where only some members work, or multiple entities working together. If submitting as an entity, that entity must meet all eligibility requirements, and the prize will be awarded to that entity.

Is an individual, team or entity eligible to submit more than one entry?

The official rules, terms and conditions do not limit the number of unique submissions an eligible entrant may submit. Once submitted, a submission cannot be altered.

Challenge focus

What problem is the challenge addressing?

Lead poisoning remains a significant public health issue in the United States, disproportionately impacting children living in communities experiencing disadvantage. Even low levels of lead in blood are associated with developmental delays, difficulty learning, behavioral issues and other harmful health effects in children. Clinical symptoms of lead exposure may be subtle and undetected by a clinical exam, the best way to determine exposure is to collect and test a blood sample at the point of care. Point-of-care blood lead testing is an essential tool for identifying childhood lead exposure and mitigating these harms.

Until 2012, children were identified as having a blood lead “level of concern” if they returned a test result of 10 µg/dL of lead in blood, or higher. Recognizing that there is no safe level of lead in blood, in 2012 CDC stopped using the term level of concern and began to use a “blood lead reference value.” This value identifies children in the United States that have more lead in their blood than the 97.5th percentile of all U.S. children. In 2012, the blood lead reference value was established to be 5 µg/dL, and in 2021 it was lowered to 3.5 μg/dL.

There is an urgent need for improved technology to detect these low levels of lead exposure through blood tests administered at the point of care. There is currently one system for point-of-care blood lead testing that is cleared by the Food and Drug Administration (FDA) and waived under the Clinical Laboratory Improvement Amendments (CLIA) so that it can be operated by healthcare workers without specialized laboratory training. It was introduced to the U.S. Market in 2006 and has a manufacturer-stated limit of detection of 3.3 µg/dL, only 0.2 µg/dL below CDC’s blood lead reference value

Despite the recognition that there is no safe level of lead in blood, no new point-of-care test systems have been made commercially available with lower limits of detection. Additionally, risks of lead contamination of a capillary (finger-stick) blood sample remain high, and can be increasingly problematic for accuracy at lower blood lead levels. The challenge seeks to identify new or existing breakthrough solutions to address these technical challenges to point of care testing.

Is the challenge seeking new or existing testing approaches?

The Lead Detect Prize seeks to accelerate the development of next-generation point-of-care blood lead tests that could detect very low blood lead levels with reduced risk of blood sample contamination from the environment. The challenge hopes to identify and foster new or existing breakthrough solutions and products for optimal lead testing in children.

Recent advancements in diagnostic technology may have opened promising new avenues for innovation and improvement. The challenge is not prescriptive about the type of methodologies and technologies used in concept papers and development plans, provided entrants describe a potential solution for improving blood lead testing at the point of care. We hope to see eligible entrants submit a wide range of solutions that address the challenge goal. 

All Phase 1 submissions will be evaluated against the equally weighted official Phase 1 evaluation criteria. Phase 1 evaluation criteria include consideration of the degree to which the proposed solution indicates potential to accurately and reliably detect low blood lead levels at the point of care, and the degree to which the proposed solution demonstrates a clear understanding of user needs, given identified point-of-care design targets, and associated clinical workflows and environments.

Are there specifications that a proposed solution is required to meet?

The Lead Detect Prize has provided target performance metrics. In Phase 1, the target performance metrics serve as guidance for an eventual FDA-cleared product. Regardless of whether a solution currently meets any of these metrics, entrants should carefully consider and address how their concepts and development plans will meet them in future. All Phase 1 submissions will be evaluated against the official Phase 1 evaluation criteria.

Prizes

How can prize money be used?

Prize competitions, by design, do not place any restrictions on how award funds are used. Winners are responsible for any applicable federal, state, and/or local laws, regulations, and policies (for example, taxes and reporting requirements) related to their prize. Winners are further responsible for any institutional, or other requirements or limitations on the use of funds that they are subject to outside of the challenge.

What are the reporting requirements related to the expenditure of prize money?

The funds awarded through this challenge are not subject to the same federal reporting requirements as funds awarded through many grant programs. Winners should comply with their regular documentation procedures for audit purposes and for any local or state reporting requirements.

Submissions

What fidelity is needed for Phase 1 concepts?

Phase 1 calls upon researchers and innovators to submit concept papers and development plans for advanced point-of-care testing solutions for lead in blood. The proposed solutions should be capable of detecting very low concentrations of lead from whole blood samples when operated by healthcare workers without specialized laboratory training.

Concept papers should describe their potential solutions for improving blood lead testing at the point of care, including a scientifically rigorous rationale for success, with any applicable supporting data. Each submission should include core technologies, specifications, and process descriptions; descriptions of the entrant team and expertise; and an achievable plan for prototype development, including estimated costs, critical assumptions, and risks.

During Phase 1, the provided target performance metrics serve as guidance for what would be required of a future, hypothetical FDA-cleared and CLIA-waived product. The requirements for submission can be found on the Submit page on the challenge website. Phase 1 submissions will be evaluated by judges against the six equally-weighted official evaluation criteria described on the challenge website.

How will submissions be evaluated?

In Phase 1, all eligible submissions will be evaluated against the Phase 1 evaluation criteria. Depending on the number of submissions, Phase 1 submissions may be initially screened by a separate review panel.

Based on their evaluation, the judges may select up to five winners. Each Phase 1 winner will receive an equal share of the Phase 1 prize pool and receive an exclusive invitation to participate in Phase 2.

Intellectual property and confidentiality

Will I retain my intellectual property?

By participating in this challenge, each entrant (whether an individual, group of individuals, or entity) grants to CDC an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, create derivative works, and display publicly the submission on the web or elsewhere, throughout the world. Each entrant will retain all other intellectual property rights in their submissions, as applicable.

Will applications be treated confidentially?

By participating in this challenge, each entrant (whether an individual, group of individuals, or entity) grants to CDC an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share, create derivative works, and display publicly the submission on the web or elsewhere, throughout the world.

In accordance with the rules, terms and conditions, each entrant must clearly delineate any confidential commercial information contained in a submission that the entrant wishes to protect as proprietary data. Such information may be kept confidential to the extent allowed under applicable federal law.

Can concepts utilize existing technologies, systems or methodologies, and leverage published literature?

Submissions may provide citations or references for background or supporting information, but for the proposed solution itself, each entrant (whether an individual, group of individuals, or entity) warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the entrant (or is an improved version of an existing work that the entrant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the entrant is aware.

Other

I would like to get involved in the challenge as a judge and/or mentor, how can I express interest?

Interested parties can email the challenge team at hello@LeadDetectPrize.com.

If my submission does not progress to Phase 2, will there be a way to stay involved?

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Submissions for Phase 1 are now closed.