Rapid Acceleration of Diagnostics Technology (RADx® Tech) Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO) Challenge Frequently Asked Questions

General

Where can I find the official rules and requirements for this challenge?

The official rules and requirements for the Rapid Acceleration of Diagnostics Technology (RADx® Tech) ACT ENDO Challenge can be found on Challenge.gov at www.challenge.gov/?challenge=radx-tech-act-endo. All Innovators interested in participating in this challenge are highly encouraged to carefully and thoroughly review the content posted on Challenge.gov, which can also be downloaded as a PDF by going to the “Resources” tab and clicking on RADx Tech ACT ENDO Challenge Announcement.

What is a challenge, and why does NIH utilize this open innovation mechanism?

Challenges, also referred to as prize competitions, are tools for incentivizing the achievement of scientific, technological, and other categories of innovation by offering monetary or non-monetary awards to challenge participants who demonstrate success. They are a mechanism that allows the public to solve problems presented by federal agencies and receive awards for the best solutions. Challenges also enable NIH to establish an ambitious goal without bearing high levels of risk or having to predict which team or approach is most likely to succeed, and then to pay only for the successful solutions. NIH has used challenges to spark new ways of thinking, solve tough problems, stimulate innovation, and advance its core mission of turning discovery into health. Challenges enable NIH Institutes, Centers, and Offices to establish ambitious goals without bearing high levels of risk and pay only for results. This mechanism also affords NIH the opportunity to engage innovators across the country who have a wide range of skillsets and diverse backgrounds, but who may not typically contribute to NIH research activities. With a focus on proven results, challenges empower untapped talent to deliver unexpected solutions to tough problems.

How is competing in a challenge different from applying for a grant, contract, or cooperative agreement from NIH?

Challenges are an effective tool within the NIH toolbox to catalyze biomedical innovation and complement our more traditional funding mechanisms. Grants, contracts, and cooperative agreements are typically awarded based on proposals for future work, while challenges typically award completed work that meets the criteria for winning a prize. Put another way, challenges retrospectively award prizes to winners for demonstrating successful accomplishment of the objectives set forth in the challenge. Importantly, grants, contracts, and cooperative agreements are usually awarded prospectively to an institution or organization to carry out an activity approved by the government in accordance with applicable rules, regulations, and policies, such as the NIH Grants Policy Statement or Federal Acquisition Regulations. Challenges, in contrast, typically award cash or non-cash prizes directly to individuals, teams, or entities and, except in limited situations, there are no restrictions on how the prize award is to be used.

Eligibility

Who is eligible to participate in this challenge?

Participants in this challenge must register and compete in either of the following capacities: as an independent Team (i.e., registering as a group of individuals competing together but not on behalf of an established organization, institution, or corporation) or as an Entity (i.e., registering as a group of individuals competing together on behalf of a legally established organization, institution, or corporation).

• For teams: Each participating Team is required to identify a Team Captain who will register and submit on behalf of the Team members. The Team Captain is responsible for all communications with the Challenge sponsors and, in the event of winning a cash prize, will be paid the prize in full. To be eligible to receive a cash prize, the Team Captain must be a citizen or permanent resident of the United States. In the event that a dispute regarding the identity of the Team Captain who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible.
• For Entities: Each participating Entity is required to identify a Point of Contact who will register and submit on behalf of the Entity. The Point of Contact is responsible for all communications with the Challenge sponsors. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact. To be eligible to receive a cash prize, the Entity must be incorporated in and maintain a primary place of business in the United States. As stated in the Participation Rules, Innovators intending to use Federal grant or cooperative agreement funds must register for and participate in the Challenge as an Entity on behalf of the awardee institution or organization. In the event that a dispute regarding the identity of the Point of Contact who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible.

Can non-U.S. citizens or non-permanent residents participate in the challenge?

Yes, non-U.S. citizens and non-permanent U.S. residents may register for and participate in a challenge as members of a Team or Entity. However, non-U.S. citizens and non-permanent U.S. residents are not eligible to win a cash prize (in whole or in part). Such individuals may participate as part of a Team or Entity that otherwise satisfies the applicable eligibility criteria and may be recognized when the results are announced. The Team Captain of a participating Team must be a U.S. citizen or U.S. permanent resident because any cash prizes will be paid directly to the Team Captain. The Point of Contact for a participating Entity does not have to be a U.S. citizen or U.S. permanent resident; however, the Entity must be incorporated in and maintain a primary place of business in the United States.

Are foreign institutions, organizations, or companies eligible to win a cash prize in the challenge?

No, any Entity (i.e., an institution, organization, company, etc.) competing in this challenge must be incorporated in and maintain a primary place of business in the United States in order to be eligible to receive a cash prize.

Submission Requirements

How do I register?

The official announcement for the RADx Tech ACT ENDO Challenge can be found on Challenge.gov at www.challenge.gov/?challenge=radx-tech-act-endo. The Challenge registration and submission portal is administered by the RADx Coordination Center operating under a contract with the NIH. Innovators can access the online portal by first going to www.cimit.org/radx-tech-act-endo. To register, Innovators will first be directed to establish an account in the registration and submission portal accessible here.

For more information on the registration process and requirements, please visit www.challenge.gov/?challenge=radx-tech-act-endo.

What happens during the submission process?

Once Innovators have completed the registration step and established an account in the online submission portal accessible at the link above, they will be asked to provide a submission Title and Executive Summary, the latter of which should include a brief description of the technology and how it will enable the diagnosis of endometriosis, and respond to a series of specific prompts.

Innovators must complete their submission and provide all of the requested information in the portal no later than 11:59 PM Eastern Time on October 11, 2024. Innovators who do not submit their complete submission in the portal by this deadline will not have their submission considered for this Challenge.

For more information on the submission process and requirements, please visit www.challenge.gov/?challenge=radx-tech-act-endo.

Prizes

How will winners of this challenge be paid their cash prize?

Teams or Entities selected to receive a prize at any stage or phase of this challenge will have that cash prize award paid directly to the bank account provided by the winning Team Captain or Entity. Cash prizes will be paid by electronic funds transfer directly to the Team Captain or to the Entity and may be subject to Federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. Please note that NIH cannot provide advice or guidance regarding federal, state, or local tax implications for winning a cash prize.

Are there any restrictions on how the cash prize must be used?

Challenges are substantially different mechanisms for advancing innovation compared to more traditional NIH grants, contracts, or cooperative agreements. There are no restrictions on nor requirements for how the cash prize award is to be used, so long as no Federal grant or cooperative agreement funds were used to develop the submission or to fund efforts in support of the submission. If an Innovator uses Federal grant or cooperative agreement funds and wins the Challenge, the prize must be paid directly to the awardee (typically, an institution, organization, or corporation) and treated as program income for purposes of the original grant or cooperative agreement in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR § 200). However, Innovators are highly encouraged to use any prize winnings to continue competing in the challenge.

Operational Questions

Can I access a recording of the Technical Webinar?

Watch the recording of the technical webinar here. Slides are available to download here. You can learn more about the Challenge, including eligibility, evaluation criteria and the submission process by reviewing the content on www.challenge.gov/?challenge=radx-tech-act-endo.

Where can I find more information about the Challenge?

RADx Tech ACT ENDO Challenge information is available on our Challenge.gov website. We anticipate publishing the full details of the Challenge, including eligibility criteria, on Challenge.gov on August 1st.

What can I expect during the Pitch Event?

Phase 1 winners will be invited to deliver a virtual presentation and demonstration of their technology as well as plans for further development and maturation. The presentation event will take place on January 23, 2025. Presentations will be evaluated by the Evaluation Panel composed of scientific/technical, clinical, regulatory, and commercialization experts from NIH, and other organizations under contract with NIBIB through the RADx Tech program. The NIH Judging Panel will review these recommendations and select the winners, pending final decisions by the Award Approving Official. Up to four (4) winners will be selected as finalists to receive a cash prize of $100,000 each and advance to Phase 3 of the Challenge. Only winners of Phase 2 will be eligible to compete in the Phase 3 Technology Development Sprint.

Further details on the logistics, timing, and format of the presentations will be provided to the Phase 1 winners at a later date.

What can I expect during Technology Development Sprint Phase?

The goal of this Phase is to support Innovators as they rapidly advance the development of their technologies over a period of 12 months and increase their likelihood for making a clinically meaningful impact in the diagnosis of endometriosis. At the beginning of Phase 3, a RADx Tech Project Team of healthcare technology commercialization and content experts will engage directly with each Innovator as part of a “deep dive” process to assess the prototype technology, identify key risk factors for accelerated development, and establish strategies to mitigate these risks, subject to final decisions by NIH. The Project Team will continue to advise and guide each Innovator throughout the Technology Development Sprint. Each Innovator will also receive free access to subject-matter expert consultants and key opinion leaders across a range of domains as part of their participation in the Challenge.

Within the first half of the Technology Development Sprint, Innovators will have the opportunity to compete for an Interim Milestone Prize of $250,000 each based upon the demonstration of substantial effort towards furthering the development and de-risking of each technology. All Innovators competing in this phase will have the opportunity to win an Interim Milestone Prize if they are determined to meet the necessary criteria; however, competing for and winning an Interim Milestone Prize is not required to continue participating in the second half of the Technology Development Sprint. At the end of the Sprint, Innovators will be assessed on objective evidence of risk factor mitigation, advancement in technology maturation, and further refinement of commercialization strategies, among other criteria. Final prizes ranging from $100,000 - $600,000 will be awarded at the conclusion of this phase.

Technical Questions

What is a Prototype?

“Prototype” refers to an early version of a medical device that can be tested in controlled laboratory settings. For the purposes of this Challenge, this can include pre-clinical devices or a workflow utilizing existing analysis devices for new clinical tests, such as biomarker panels.

What is the difference between a pain profile and identifying Endometriosis?

For purposes of the RADx Tech ACT ENDO Challenge, technologies must detect endometriosis in adults and/or adolescents, differentiating from a profile/marker of pain. Detection and discernment may be specifically for symptomatic women or as a screening tool for asymptomatic and symptomatic women.

What does “non-invasive” mean?

“Non-invasive” is defined as approaches that do not require incision, [non-blood] medical tissue removal, or contact with a bodily orifice beyond natural orifices. For example, venipuncture, finger pricks, analysis of menstrual effluent, and transvaginal imaging modalities will be considered within scope of this Challenge, but endometrial biopsies will be considered “invasive” and therefore non-responsive.