RADx® Tech Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays - CIMIT MAIN

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

Overview Prizes Timeline Eligibility How To Participate Evaluation Criteria Resources Sponsors FAQs

Overview

The Rapid Acceleration of Diagnostics Technology (RADx® Tech) Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO) Challenge will award $3.0 million in prizes to accelerate the development of innovative technologies for the diagnosis of endometriosis. Endometriosis is a chronic inflammatory condition characterized by the growth of uterine endometrium-like tissue outside the uterus; the often-debilitating condition affects approximately 1 in 10 reproductive-aged women worldwide. Novel approaches are urgently needed to identify those who are afflicted with the condition and to spur the development of new treatments and cures. Successful technologies developed in this Challenge will shorten the time to diagnosis, eliminate the invasiveness of current techniques, and/or improve accessibility, safety, convenience, and costs of diagnosis. Examples of desired technologies include, but are not limited to, imaging technologies, in vitro diagnostic devices, clinical laboratory tests, wearable devices, smartphone-enabled diagnostic tools, integrated sensing technologies, and digital health platforms.

Innovators participating in the RADx Tech ACT ENDO Challenge will initially submit a proposal describing in detail their prototype diagnostic technology, anticipated clinical impact, and plans for continued development and implementation. Winners of Phase 1 will be invited to deliver a virtual presentation and technology demonstration in Phase 2. Winners of Phase 2 will receive a $100,000 cash prize each and advance to the Phase 3 technology development sprint where they will de-risk and further mature their technologies with support by a RADx Tech Project Team of healthcare technology commercialization and content experts. Participants in Phase 3 will compete for interim and final cash prizes ranging from a cumulative $350,000 - $850,000 each.

Please visit challenge.gov for additional details and official rules.

Prizes

The total prize purse for this Challenge is $3,000,000. Prizes will be awarded following the successful completion of each phase of the Challenge in the following amounts:

Phase 1: up to 8 winners will be selected as semi-finalists to advance to Phase 2
Phase 2: $100,000 per winner; up to 4 winners will be selected as finalists to advance to Phase 3
Phase 3:
- Interim Milestone Prize: $250,000 per winner, up to 4 winners
- Grand Prizes:
  - 1st place = $600,000
  - 2nd place = $500,000
  - 3rd place = $400,000
  - Runner up = $100,000

Timeline

August 12, 2024: Challenge launched and Submission portal opens

August 28, 2024, 11:00AM - 12:00PM ET: Informational webinar (Download slides.)

Phase 1:

October 11, 2024: Submission Deadline
October - December 2024: Judging Period
December 15, 2024 (anticipated): Winners Announced

Phase 2:

January 23, 2025: Technology Demonstration and Pitch Presentation Event
February 2025: Judging Period
March 1, 2025 (anticipated): Winners Announced

Phase 3:

March 2025 - March 2026: Technology Development Sprint
July 1, 2025: Interim Milestone Prize Deadline
September 2025: Interim Milestone Winners Announced
January - February 2026: Final Judging Period
March 2026: Final Winners Announced

Eligibility

The RADx Tech ACT ENDO Challenge requires that diagnostic technologies submitted should be at least at the working prototype stage, accompanied by computational, in vitro, and/or in vivo data that validates the proof of concept. These technologies must be non-invasive and capable of detecting endometriosis in adults and/or adolescents, with the ability to distinguish this condition from general pain markers. The solutions should not only differentiate symptomatic from asymptomatic individuals but should also be designed as either targeted diagnostic tools or broader screening mechanisms. Eligible technologies should adhere to existing standards, consider regulatory requirements, and be designed for seamless integration into current healthcare settings, ensuring ease of use by medical professionals. They should also possess technical features such reliability, accuracy, precision, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, and inclusion of software to support decision-making where appropriate. Finally, there should be a demonstrable pathway for these technologies to enter the market within the next decade (10 years), ensuring they are not only innovative but also practically implementable within foreseeable timelines.

Innovators must formally register and compete as either 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). Innovators may include, but are not limited to, teams of individuals, start-ups, small- or mid-size businesses, large businesses, non-profit organizations, and academic or independent research institutions. Innovators intending to use Federal grant or cooperative agreement funds, if permissible, must participate in the Challenge as an Entity on behalf of the awardee institution or organization.

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 directly and in full. To be eligible to receive a cash prize, the Team Captain must be a citizen or permanent resident of the United States.
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 and in full 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.

How to Participate

Review the full Challenge Announcement. Interested participants in the Challenge should carefully and thoroughly read the detailed Challenge description, eligibility and participation rules, judging criteria, and submission instructions.
Watch the informational webinar and view the slides. NICHD and its partners hosted a public webinar on August 28, 2024 from 11:00AM to 12:00PM ET for interested participants to learn more about the RADx Tech ACT ENDO Challenge and to get their questions answered.
Register for the Challenge. Each Innovator should determine whether they will compete in the Challenge as either a Team or on behalf of an Entity, and then establish an account in the submission portal.
Submit your entry to the Challenge. Ensure your Team or Entity has thoroughly responded to each of the questions and prompts and fully submitted your entry no later than October 11, 2024 at 11:59pm Eastern Time.

Evaluation Criteria

Scientific/Technological:

Does the submission sufficiently describe the biological, chemical, and/or physical principles of the diagnostic technology, and mechanisms of sample or data collection, analysis, and reporting of results?
To what extent has the technology been demonstrated to accurately detect, diagnose, and/or monitor endometriosis in pre-clinical models or in adults and/or adolescents?
Does the submission provide sufficient data and other evidence to demonstrate proof of concept of the technology?

Clinical:

What is the likelihood that the technology, if successful, will either shorten the time to diagnosis, eliminate the invasiveness of current techniques, and/or improve the accessibility, safety, convenience, or cost of diagnosis?
Does the implementation of the technology have real-world clinical utility, i.e., can it deliver clinically actionable information that will inform an individual’s treatment?
Can the technology be efficiently integrated into the intended healthcare environments and processes (i.e., easily used by healthcare professionals as part of their routine protocols), or can the technology overcome barriers to the entry of novel approaches within current clinical care settings?

Commercialization & Regulatory:

Are the proposed milestones and deliverables feasible within the proposed timeframe of the Phase 3 – Technology Development Sprint and in close alignment with the goals of this Challenge?
Are the plans to obtain required clearance and approval from the applicable regulatory agency, such as the U.S. Food and Drug Administration, feasible and appropriate?
Does the submission address solutions to the likely regulatory challenges on a realistic schedule to achieve the stated goals?
What is the commercial potential of the technology, and what is the likelihood that it could lead to a marketable product, process, or service?
Assuming the technology works as anticipated, how well is it likely to be manufactured and implemented at scale in an economically viable way?

Innovation:

Does the technology represent a scientific or technical approach that is novel, unique, and a significant advancement over the current standard of care or approaches, or represent the innovative implementation of existing technology?
Will the technology fill a needed gap and significantly advance progress towards the noninvasive diagnosis of endometriosis?

Team:

Do the team members have sufficient scientific and clinical expertise and experience in the biology and diagnosis of endometriosis?
To what extent does the team possess the necessary expertise and resources to bring a new diagnostic technology to market? If not, are the plans for obtaining the requisite expertise and resources reasonable?

Resources

For additional information, contact the Challenge sponsors at nichdactendo@mail.nih.gov.

Frequently Asked Questions (FAQs)

Please review the FAQs available here.