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Overview

Summary of the Challenge

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[1] 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.

Subject of the Challenge

Background

Endometriosis is a chronic, debilitating condition that is associated with symptoms including chronic pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, and infertility[2-3], as well as an increased risk for ovarian cancer[4], depression[5], migraines, lupus, multiple sclerosis, and other pain and autoimmune conditions[6]. Despite the severe impact of endometriosis on quality of life, diagnosis may be delayed up to 10 years due to a normalization of intense menstrual pain by patients and healthcare providers, and the requirement for surgical visualization[7-9]. This delay results in prolonged patient suffering, increased risk for the development of comorbidities, and greater socioeconomic cost. Current medical and surgical treatments, which carry substantial risks and side effects, are associated with a high rate of recurrence and are best considered temporizing rather than curative[10-11]. Non-invasive diagnostics and new treatments have been slow to develop, in part due to the need for better understanding of the pathogenesis and pathophysiology of the disorder.

Diagnosis of endometriosis currently requires laparoscopic surgery followed by histological confirmation as the gold standard[12]; it is driven by diagnostic biases that exist in the absence of a non-invasive diagnostic that can detect all forms and stages of endometriosis[13-15]. For example, the most common form of endometriosis, superficial peritoneal endometriosis (accounting for ~80% of cases), is often only diagnosed as an incidental surgical finding or in women with the most severe symptoms who are willing and able to risk surgery to receive a diagnosis. Even among those women who receive a referral (in itself a process wrought with disparities where sex, race, and socioeconomic status can affect the perception of female pain), laparoscopic surgery is invasive, requires recovery time, and presents access barriers (e.g., geographic location of endometriosis specialists, economic costs, insurance coverage) for many patients. It also does not correlate with severity of symptoms and provides limited predictive value prognosis or progression of disease. These limitations mean that only the most life-affecting symptomatology is funneled to diagnostic surgery; cases with symptomatology that is masked as other conditions, normalized by patients and providers, or related to lesser-known comorbidities of endometriosis are missed.

Transvaginal ultrasound or magnetic resonance imaging can be used to diagnose ovarian endometriomas and deep infiltrating endometriosis subtypes only in certain anatomic locations and at certain stages of disease; these techniques are not yet reliably sensitive and accurate enough for definitive diagnosis. Additionally, diagnostic accuracy via laparoscopic and imaging techniques is limited in providers and technicians without specialized training. Diagnostic biomarkers to date have proven non-specific or unreliable[16-18] and are not advised for use by professional society diagnostic guidelines [8], despite tests claiming accuracy.

These barriers to diagnosis have lasting impacts on treatment and further research. Because a diagnosis is invasive and/or unreliable, clinicians may choose to treat without one. The suspicion of endometriosis may be treated with hormonal therapies or analgesics, with no attention paid to potential differences in endometriosis staging, subtype, size, location, or confounding comorbidities. Further, the diagnostic delay combined with biases of diagnosing only cases with the most severe symptoms means that even research trials must rely on cases heavily skewed towards advanced disease in white, socioeconomically advantaged populations for whom barriers to expert clinicians and specialty imaging modalities are lower. Women with African or Asian ancestry are underrepresented in diagnoses. Despite the known association with cancers, infertility, body-wide pain conditions, and autoimmune conditions, endometriosis that presents without debilitating pain is also underdiagnosed.

Increased research and development are urgently required to deliver non-invasive diagnostics, improved treatments, and, ultimately, prevention and cure for endometriosis. The overall goal of the RADx Tech ACT ENDO Challenge is to accelerate the development of non-invasive diagnostic technologies that can shorten the time to diagnosis, eliminate the invasiveness of current techniques, and/or improve accessibility, safety, convenience, and costs of diagnosis. While the development of novel diagnostic modalities is encouraged in this Challenge, the application or improvement of existing advanced imaging or other techniques that can reliably, reproducibly, and sensitively help non-invasively diagnose endometriosis is also welcome. Submissions from Innovators who have devices or approaches with likely utility in the diagnosis of endometriosis but who otherwise have not yet applied their technological expertise to gynecologic research are welcome, so long as there is sufficient data demonstrating the feasibility of the approach. Innovators should also consider how their prototype technologies will help address disparities in the diagnosis of endometriosis among underrepresented and underserved populations. Diagnostics developed under this challenge can be directed specifically to symptomatic populations or as a screening modality for symptomatic and asymptomatic women.

Challenge Design

The RADx® Tech Innovation Funnel Approach

The Rapid Acceleration of Diagnostics Technology (RADx® Tech) program[19], created and led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), is designed to speed innovation in the development, commercialization, and implementation of medical diagnostics and devices. RADx Tech utilizes an innovation funnel approach with stage-gated, milestone-based funding combined with a deep dive assessment to rapidly validate and de-risk novel technologies through a seamless pipeline. Increasing amounts of financial support and resources are provided to technology developers in an increasingly competitive process. True to the funnel approach, the pool of developers is continually narrowed across each phase as only the top performing teams advance. This approach aims to compress the typical timeline to market entry and the delivery of new medical technologies into a variety of settings including hospitals, clinics, and homes. In addition to financial rewards, developers receive wrap-around support from subject matter expert consultants to help them address scientific/technical, clinical, regulatory, and commercialization requirements. NICHD is partnering with NIBIB to leverage the RADx Tech program and launch this Challenge to drive innovation in the diagnosis of endometriosis.

Phase 1 – Submission

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. Submissions describing the development, advancement, and/or validation of new, or the repurposing of existing, devices, imaging techniques or probes, artificial intelligence or machine learning based modalities, clinical laboratory tests, and/or other methods for non-invasive diagnosis of endometriosis are welcome. However, Innovators should already have developed a working prototype (as described above) with computational, in vitro, and/or in vivo data demonstrating the proof of concept. Technologies at the conceptual design or idea stage will not be considered responsive and are unlikely to be selected to advance. For the initial submission, Innovators must also provide a robust plan for further development of the technology to meet the Challenge’s criteria. Submissions must include proposed milestones and deliverables for the Phase 3 – Technology Development Sprint that are quantitative, and with clear go/no-go criteria. Innovators are also encouraged to utilize a multidisciplinary approach in furthering the development of their technology, consulting with clinical and surgical experts experienced in diagnosis of endometriosis, as well as those who have research design, and translational or device engineering expertise as appropriate.

These proposals will be reviewed, from which up to eight (8) winners will be selected as semi-finalists and be invited to advance to Phase 2. Only winners of Phase 1 will be eligible to compete in Phase 2.

Phase 2 – Technology Demonstration and Pitch Presentation Event

During this phase, Innovators will participate in a virtual event and deliver a pitch presentation and demonstration of the technology as well as plans for further development and maturation. Further details on the logistics, timing, and format of the presentations will be provided to the Phase 1 winners at a later date. The presentations will be evaluated by a panel composed of scientific/technical, clinical, regulatory, and medical device commercialization experts. Up to four (4) winners of Phase 2 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 Phase 3.

Phase 3 – Technology Development Sprint

During the third and final Phase of the Challenge, 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 objective 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. 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 Phase 3, 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 the Technology Assessment 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 Phase 3. At the end of the Technology Development 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 Phase 3.

Technology Requirements

Diagnostic technologies submitted to the RADx Tech ACT ENDO Challenge must:

• At a minimum, be a working prototype (as defined previously) of a technology with computational, in vitro, and/or in vivo data demonstrating the proof of concept.
• Be non-invasive.[20]
• 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.
• Incorporate existing standards and consider regulatory requirements where appropriate.
• Be capable of efficient integration into the intended healthcare environments and processes (i.e., easily used by healthcare professionals as part of their routine protocols), or capable of overcoming barriers to the entry of novel approaches within current clinical care settings.
• Possess additional technical features such as: reliability, accuracy, precision, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, and inclusion of software to support decision-making where appropriate.
• Have a reasonable likelihood of market entry within the next 10 years.

Areas of high priority for the RADx Tech ACT ENDO Challenge include, but are not limited to, technologies that:

• Utilize new or existing diagnostic biomarkers from serum, saliva, cervicovaginal secretions, or other samples that can be collected non-invasively. The use of menstrual effluent as a source of samples is of particular interest.
• Are implementable at the point-of-care.
• Accurately distinguish between non-malignant (“benign”) endometriomas and malignancy.
• Can be utilized in an adolescent population for proof of concept of early detection approaches.
• Are applicable to diverse and understudied populations.

Proposals focused on any the following will be considered non-responsive for this Challenge and will not be considered for prizes:

• Exploratory basic research studies or screens to identify new biomarkers for endometriosis.
• Diagnostic technologies that require biopsies and laparoscopic or other surgical interventions of any kind.
• Approaches without a focus on individuals at risk for or with endometriosis.
• The diagnosis of bacterial vaginosis, HPV, or screening for HPV cervical lesions.
• Proposals that solely or predominately focus on the detection of ovarian or uterine cancer, without effectively distinguishing it from non-malignant (“benign”) endometriosis.
• Proposals with a primary focus on co-morbid conditions (e.g., depression, migraines).
• Projects investigating the medical or psychosocial impacts of current treatments on health.
• Large-scale epidemiologic studies, including those that estimate the incidence/prevalence of endometriosis.

Technology Types

Examples of desired technologies include, but are not limited to:

• Imaging technologies
• In vitro diagnostic devices
• Clinical laboratory tests
• Integrated sensing technologies
• Wearable devices
• Digital health platforms utilizing advanced computational approaches (such as machine learning or artificial intelligence) to predict likelihood of endometriosis for better targeted clinical triaging.

Partners: The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a component of the 2023 ��ѿ��ý, is co-sponsoring this Challenge.

Dates

• Challenge Launch: August 12, 2024
• Registration and Submission Portal Opens: August 12, 2024
• Informational Webinar: August 28, 2024 ()
• Phase 1:
  • Submission Deadline: October 11, 2024
  • Judging Period: October – December, 2024
  • Winners Announced: December 15, 2024 (anticipated)
• Phase 2:
  • Technology Demonstration and Pitch Presentation Event: January 23, 2025
  • Judging Period: February 2025
  • Winners Announced: March 1, 2025 (anticipated)
• Phase 3:
  • Technology Development Sprint: March 2025 – March 2026
  • Interim Milestone Prize Deadline: July 1, 2025
  • Interim Milestone Winners Announced: September 2025
  • Final Judging Period: January – February, 2026
  • Final Winners Announced: March 2026 (anticipated)

Statutory Authority to Conduct the Challenge

NICHD is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. Founded in 1962, the general purpose of NICHD is the conduct and support of research, training, health information dissemination, and other programs with respect to gynecologic health, maternal health, child health, intellectual disabilities, human growth and development, including prenatal development, population research, and special health problems and requirements of mothers and children [42 U.S.C. § 285g]. The Institute’s mission includes improving reproductive health, enhancing the lives of children and adolescents, and optimizing abilities for all, and its vision is “Healthy pregnancies. Healthy children. Healthy and optimal lives.” This challenge aligns with NICHD’s statutory authority and promotes its mission and vision by accelerating the development of innovative technologies that will aid in the diagnosis of endometriosis and ultimately improve gynecologic and reproductive health.

References

1. “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.
2. Gete DG, Doust J, Mortlock S, et al. Associations between endometriosis and common symptoms: findings from the Australian Longitudinal Study on Women’s Health. Am J Obstet Gynecol 2023;229:536.e1-20. doi: 10.1016/j.ajog.2023.07.033. PMID: 37499990.
3. Practice Committee of the American Society for Reproductive Medicine. Endometriosis and infertility. Fertil Steril. 2006 Nov;86(5 Suppl 1):S156-60. doi: 10.1016/j.fertnstert.2006.08.014. PMID: 17055813.
4. Kvaskoff M, Mahamat-Saleh Y, Farland LV, et al. Endometriosis and cancer: a systematic review and meta-analysis. Hum Reprod Update. 2021 Feb 19;27(2):393-420. doi: 10.1093/humupd/dmaa045. PMID: 33202017.
5. Koller D, Pathak GA, Wendt FR, et al. Epidemiologic and Genetic Associations of Endometriosis With Depression, Anxiety, and Eating Disorders. JAMA Netw Open. 2023 Jan 3;6(1):e2251214. doi: 10.1001/jamanetworkopen.2022.51214. PMID: 36652249; PMCID: PMC9856929.
6. Rahmioglu N, Mortlock S, Ghiasi M, et al. The genetic basis of endometriosis and comorbidity with other pain and inflammatory conditions. Nat Genet. 2023 Mar;55(3):423-436. doi: 10.1038/s41588-023-01323-z. Epub 2023 Mar 13. PMID: 36914876; PMCID: PMC10042257.
7. Mak J, Leonardi M, Condous G. 'Seeing is believing': arguing for diagnostic laparoscopy as a diagnostic test for endometriosis. Reprod Fertil. 2022 Jun 10;3(3):C23-C28. doi: 10.1530/RAF-21-0117. PMID: 35794928; PMCID: PMC9254269.
8. Becker CM, Bokor A, Heikinheimo O, et al. ESHRE guideline: endometriosis. Hum Reprod Open. 2022 Feb 26;2022(2):hoac009. doi: 10.1093/hropen/hoac009. PMID: 35350465; PMCID: PMC8951218.
9. As-Sanie S, Black R, Giudice LC, et al. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18. PMID: 30790565.
10. Kalaitzopoulos DR, Samartzis N, Kolovos GN, et al. Treatment of endometriosis: a review with comparison of 8 guidelines. BMC Womens Health. 2021 Nov 29;21(1):397. doi: 10.1186/s12905-021-01545-5. PMID: 34844587; PMCID: PMC8628449.
11. França PRC, Lontra ACP, Fernandes PD. Endometriosis: A Disease with Few Direct Treatment Options. Molecules. 2022 Jun 23;27(13):4034. doi: 10.3390/molecules27134034. PMID: 35807280; PMCID: PMC9268675.
12. Practice Bulletin No. 114: Management of Endometriosis. Obstetrics & Gynecology 116(1):p 223-236, July 2010. doi: 10.1097/AOG.0b013e3181e8b073. PMID: 20567196.
13. Horne AW, Missmer SA. Pathophysiology, diagnosis, and management of endometriosis. BMJ. 2022 Nov 14;379:e070750. doi: 10.1136/bmj-2022-070750. PMID: 36375827.
14. Taylor HS, Kotlyar AM, Flores VA. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet. 2021 Feb 27;397(10276):839-852. doi: 10.1016/S0140-6736(21)00389-5. PMID: 33640070.
15. Young SL. Nonsurgical approaches to the diagnosis and evaluation of endometriosis. Fertil Steril. 2024 Feb;121(2):140-144. doi: 10.1016/j.fertnstert.2023.12.020. Epub 2023 Dec 15. PMID: 38103884.
16. Gupta D, Hull ML, Fraser I, et al. Endometrial biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Apr 20;4(4):CD012165. doi: 10.1002/14651858.CD012165. PMID: 27094925; PMCID: PMC6953323.
17. Nisenblat V, Bossuyt PM, Shaikh R, et al. Blood biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 May 1;2016(5):CD012179. doi: 10.1002/14651858.CD012179. PMID: 27132058; PMCID: PMC7076288.
18. Liu E, Nisenblat V, Farquhar C, et al. Urinary biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2015 Dec 23;2015(12):CD012019. doi: 10.1002/14651858.CD012019. PMID: 26695425; PMCID: PMC7081124.
20. For the purpose of this Challenge, “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.

Timeline

8/12/2024 09:00 AM EDT: Challenge Launch

8/12/2024 09:00 AM EDT: Challenge Registration & Submission Portal Opens

10/11/2024 11:59 PM EDT: Phase 1 Submission Deadline

1/23/2025 09:00 AM EST: Phase 2 Technology Demonstration & Pitch Event

3/01/2025 09:00 AM EST: Phase 3 Technology Development Sprint Begins

3/01/2026 05:00 PM EST: Phase 3 Technology Development Sprint Ends

Prize Description

Amount of the Prize:

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

Prize funds that remain unawarded after the selection of winners for each phase may be rolled over into a subsequent phase and added to those prize payments; however, any decision to increase any individual prize amounts from what is outlined above is entirely at the discretion of NICHD.

Award Approving Official:

The Award Approving Official for this Challenge will be the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Payment of the Prize:

Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. Prizes will exclusively be paid to the Team Captain or to the Entity participating in this Challenge (see Eligibility Rules). HHS/NIH/NICHD will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. All Innovators participating in this Challenge are highly encouraged, but not required, to request and obtain a free Unique Entity ID, if they have not already done so, via SAM.gov as this will expedite prize payment. Additional information can be found at .

HHS/NIH/NICHD reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, or any part of it, for any reason, and/or (b) not award any prizes if no submissions are deemed worthy. 

Eligibility Requirements

To be eligible to win a cash or non-cash prize under this Challenge, an Innovator (whether participating as a Team or Entity) —

• Shall have registered to participate in the Challenge under the rules promulgated by the NIH as published in this announcement;
• Shall have complied with all the requirements set forth in this announcement;
• In the case of an Entity, shall be incorporated in and maintain a primary place of business in the United States. In the case of a Team, the Team Captain shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a Team or Entity that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning Team or Entity, if applicable, may be recognized when the results are announced.
• Shall not be a federal entity or federal employee acting within the scope of their employment;
• Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;
• Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge;
• Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
• In the case of any individuals participating on a Team or on behalf of an Entity, shall be 18 years of age or older at the time of submission.

Participation Rules

1. An Innovator (whether participating as a Team or Entity) may not use Federal funds from a grant award, cooperative agreement, or other transaction (OT) award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions unless use of such funds is consistent with the purpose, terms, and conditions of the grant award, cooperative agreement, or OT award. Innovators intending to use Federal grant, cooperative agreement, or OT award funds must register for and participate in the Challenge as an Entity on behalf of the awardee institution, organization, or entity. If an Innovator uses Federal grant, cooperative agreement, or OT award funds and wins the Challenge, the prize must be treated as program income for purposes of the original grant, cooperative agreement, or OT award in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR § 200).
2. Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.
3. By participating in this Challenge, each Innovator (whether participating as a Team or Entity) agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.
4. Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Innovator (whether participating as a Team or Entity) participating in the Challenge is required to obtain liability insurance, or demonstrate financial responsibility in order to participate in this Challenge, or agree to indemnify the federal government against third party claims for damages arising from or related to Challenge activities in order to participate in this Challenge.
5. An Innovator (whether participating as a Team or Entity) shall not be deemed ineligible because the Innovator used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Innovators participating in the Challenge on an equitable basis.
6. By participating in this Challenge, each Innovator (whether participating as a Team 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 Innovator (or is an improved version of an existing work that the Innovator 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 Innovator is aware.
7. By participating in this Challenge, each Innovator (whether participating as a Team or an Entity) grants to the NIH a nonexclusive, nontransferable, irrevocable, paid-up, royalty-free, worldwide license to utilize the full contents of the submission for the purposes of informing the design of ongoing or future programs or activities supported by NIH. Additionally, each Innovator selected to win a prize under this Challenge grants to the NIH an irrevocable, paid-up, nonexclusive worldwide license to reproduce, publish, post, link to, share, and display publicly the Title and Executive Summary components of the submission on the web or elsewhere. Each Innovator will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Innovator must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Innovator’s rights to the federal government if they are selected as a winner. To receive a prize award, Innovators will not be required to transfer their intellectual property rights to NIH, but Innovators must grant to the federal government the nonexclusive licenses recited herein.
8. Each Innovator (whether participating as a Team or Entity) agrees to follow all applicable federal, state, and local laws, regulations, and policies.
9. Each Innovator (whether participating as a Team or Entity) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Innovator’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.
10. As a condition for winning a cash prize in this Challenge, each Innovator (whether participating as a Team or Entity) that has been selected as a winner must complete and submit all requested winner verification and payment documents to NIH within 15 business days of formal notification. Failure to return all required verification documents by the date specified in the notification may be a basis for disqualification of a cash prize winning submission.

Additional Resources

RADx Tech ACT ENDO Challenge Announcement 2024-08-12 (.pdf)

Informational Webinar: An informational webinar for interested participants was held on August 28, 2024. Click to of the informational webinar and view the slides. 

Contact

Have a question or comment about this challenge? Email NICHDACTENDO@mail.nih.gov.

Winners

Phase 1: Submission

NIH is pleased to announce the following winners of the Submission Phase of the RADx Tech ACT ENDO Challenge. Each winner will advance to the Phase 2 Technology Demonstration and Pitch Event and compete for one of four $100,000 prizes and the opportunity to participate in the Phase 3 Technology Development Sprint.

• 3CPM Company, Inc., Sparks Glencoe, MD
• EndoCyclic Therapeutics, Irvine, CA
• Endometrics Ltd, San Francisco, CA
• Feinstein Institutes – Northwell Health, Manhasset, NY
• Sur180 Therapeutics, INC, McAllen, TX
• NextGen Jane, Oakland, CA
• Rudra Therapeutics, Houston, Tx
• Washington University, St. Louis, MO

Phase 2: Technology Demonstration & Pitch Event

NIH is pleased to announce the following Phase 2 winners. Each winner received a $100,000 prize and will advance to the Phase 3 Technology Development Sprint.

• 3CPM Company, Sparks Glencoe, MD
• Endometrics, San Francisco, CA
• Feinstein Institutes – Northwell Health, Manhasset, NY
• Washington University, St. Louis, MO

Phase 3: Technology Development Sprint 

The 2023 ��ѿ��ý is pleased to announce four grand prize winners of the Rapid Acceleration of Diagnostics Technology Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays challenge.  

1st place, $600,000 prize 

Endometrics, San Francisco, CA  
Menstrual fluid as an endometriosis diagnostic  

2nd place, $500,000 prize 

Feinstein Institutes for Medical Research – Northwell Health, Manhasset, NY 
Menstrual fluid as an endometriosis diagnostic 

3rd place, $400,000 prize 

3CPM Company, Sparks Glencoe, MD 
Electroviscerography (EVG) as an endometriosis diagnostic 

Runner up, $100,000 prize 

Washington University, St. Louis, MO 
Uterine peristalsis imaging (UPI) as an endometriosis diagnostic