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NOT-HD-24-027 - Notice of Information: NICHD to Change from a Research Opportunity Announcement for ACT ENDO (Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays) to a Prize Competition Announcement

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this Notice is to alert the community that NIH plans to publish a Research Opportunity Announcement (ROA) to invite applications from eligible organizations to engage with NICHD to develop, advance, and/or validate new devices, biomarkers, and/or methods or repurpose existing devices for non-invasive diagnosis of endometriosis. The ROA will consist of two stages: 1) An open call for pre-applications from applicants with an interest in submitting an application to “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)”; and 2) An invitation-only stage to apply to the  “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)” Research Opportunity Announcement to be offered in summer of 2024.

No awards will be made in response to the Stage 1 preapplication step, but Stage 1 participation is required to receive an invitation to Stage 2. An award under Stage 2 will be issued as an Other Transactions Agreement (OTA), which is not a grant, contract, or cooperative agreement. OTAs will involve active NIH program management.

Research Initiative Details

Increased research is urgently required to improve our understanding of endometriosis initiation, progression, and pathophysiology as a path toward non-invasive diagnostics, improved treatments, and, ultimately, prevention and cure. Projects supported by the ACT ENDO initiative will aim to shorten the time to diagnosis, decrease the invasiveness of current techniques, and/or improve accessibility, safety, convenience, and costs of diagnosis. These projects will also encourage collaborations with investigators and entities who have not yet applied their expertise to gynecologic research, thereby expanding the potential scientific insight and investigational toolkit available to these projects. It is anticipated that, through rigorous collaborative R&D efforts, safe and effective techniques, instruments, and devices can be developed for use in the evaluation and diagnosis of people with endometriosis.

The tools and technologies developed with funding through this ROA are expected to be integrated systems or, if they are novel components, to be easily integrated into existing systems. Some other technical features that are expected are the following: reliability, accuracy, precision, robustness, safety, simplicity, reliance on the appropriate baseline information, contextual awareness, and inclusion of software to support decision-making where appropriate. Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate. In addition, improved access to underserved areas, and cost-effectiveness should be highlighted.

For the purpose of this ROA, non-invasive procedures will be defined as “procedures 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 responsive to this ROA, but endometrial biopsies will be considered “invasive” and therefore non-responsive.

Projects of high priority for this ROA include, but are not limited to:

• Identification and validation of new 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.
• Application of, or improvement to, existing advanced imaging techniques that can reliably, reproducibly, and sensitively help diagnose endometriosis. The development of novel modalities is also encouraged. The development of targeted probes used for such imaging is also of interest.
• Development or application of machine learning or artificial intelligence to electronic health records, imaging, and/or other data sets to predict potential endometriosis for better targeted clinical triaging.
• Studies that prioritize the inclusion of, and eventual availability and application of, all developed markers, tools, and technologies, to minority and underserved populations. Studies powered to detect differences or applicability to minority populations are especially of interest.
• Studies utilizing data obtained from state-of-the-art genomic, epigenomic, transcriptomic and other ‘omic technologies to address the diagnosis of endometriosis.
• Studies that utilize an adolescent population for proof of concept of early detection approaches.
• Point of care technologies that can efficiently, inexpensively, and rapidly diagnose a patient with endometriosis.
• Approaches to accurately distinguish between non-malignant (“benign”) endometriomas and malignancy.

Projects of lower priority for this ROA include, but are not limited to:

• Studies of apps or other mobile technologies to collect only self-reported data in the absence of biological sampling or clinical confirmation of diagnosis.
• Investigation of the influence of infectious disease status on the reliability, accuracy, or accessibility of non-invasive diagnostics for the named gynecologic conditions.

Projects that will be considered non-responsive for this ROA and withdrawn without review include:

• Biopsies and laparoscopic or other surgical interventions of any kind.
• Projects without a focus on individuals at risk for or with endometriosis.
• The study of bacterial vaginosis, HPV, or screening for HPV cervical lesions.
• Studies that solely or predominately focus on the detection of ovarian or uterine cancer, without effectively distinguishing it from non-malignant (“benign”) endometriosis.
• Studies 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.

The Stage 1 “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)” pre-application will be a required first step in the application process to submit to the subsequent Stage 2 Research Opportunity Announcement (ROA). Applicants whose Stage 1 pre-applications are found to be meritorious and programmatically relevant will be invited to submit a full application to the Stage 2 “Advancing Cures and Therapies and ending ENDOmetriosis diagnostic delays (ACT ENDO)” ROA. There will be substantial interaction with NIH Program Staff leading to the development of programmatic and budget elements for an acceptable Stage 2 application. Stage 2 applications must include a copy of the Invitation to Submit from the ACT ENDO program as a requirement for submission. The invitation to submit a Stage 2 application is not an indication of any award.

Applications solicited under this funding opportunity will be expected to be managed by interdisciplinary teams that possess the necessary clinical, surgical, research design, and device engineering expertise as appropriate. Interested commercial stakeholders may be involved either as collaborators on academic investigator-initiated applications or as direct leads.

Applicants may be asked to partner with supportive biomarker discovery or translational partnerships among government, industry, researchers, and other potential partners for Stage 2 of the initiative.

As with all NIH supported research, details regarding human subjects research are expected, including data safety and monitoring plans and, if needed, plans for a Data and Safety Monitoring Board (DSMB). Prospectively planning for how scientific data will be managed and ultimately shared through submission of, and adherence to, a Data Management and Sharing Plan (DMSP) will also be required, in accordance with NIH policy. 

Funding Information

Estimated Total Funding                    TBD

Expected Number of Awards           TBD

Estimated Award Ceiling                    TBD

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

For scientific inquiries: 

Candace Tingen, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD]
Telephone: 301-435-6971
Email: [email protected]

For OTA mechanism inquiries:

Artisha Wright
Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD]
Telephone: 301-827-1844
Email: [email protected]