Skip to main content
An official website of the United States government
Email

NIH/NCI 474 - Point of Care Technologies for GI Cancer Prevention and Early Detection

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will NOT be accepted.

Number of anticipated awards: 3-5

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,250,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Gastrointestinal (GI) tract (esophagus, stomach, small and large intestine, rectum, anus) cancers account for approximately 19% and 23% of global cancer incidence and mortality. While the burden predominately lies in high and upper-middle income countries, an epidemiologic shift is leading to increased incidence in low- and middle-income countries (LMIC). Apart from colorectal cancer (CRC), where there have been advances in early detection and treatment, prognosis in other GI tract cancers tends to be poor due to the late stage of most diagnoses. Within the United States (US), disparities are largely attributed to late presentation of CRC, and African Americans and Hispanics as well as rural populations face increased CRC mortality. Similarly, while gastric cancer is less common in the US, incidence in Asians, Blacks, and Hispanics is significantly higher than in Whites. For esophageal cancer, although early detection increases treatment options, the burden is greater in minorities, immigrants, and lower socioeconomic groups, who present at more advanced stage. Finally, while risk-stratified early detection approaches have been implemented for esophageal adenocarcinoma (EAC), there are no recommended screening approaches for average-risk individuals or for esophageal squamous cell carcinoma (ESCC), which is seen more commonly in LMICs and accounts for 90% of global esophageal cancers.

For all these cancers, there is a need for affordable and scalable point-of-care tests (POCTs) that can effectively screen for precancerous conditions and early cancers, while intervention is still possible. Moreover, the parallel needs in high-income countries (HICs) and LMICs call for a reciprocal innovation approach based on bidirectional, mutually beneficial research, where the resultant tests are designed for broad applicability across both the HICs and LMICs.

Project Goals

The goal of this topic is to develop affordable and scalable point-of-care tests (POCTs) that can effectively screen for precancerous conditions and early cancers in the GI tract. Applicants to this contract topic can propose to modify an existing technology such that it can be used for GI tract cancer prevention/early detection at the point-of-need; simplify or add new features to a device to enable the device to operate outside of a laboratory; and/or apply existing or emerging technologies that have not been previously used for GI cancer prevention/early detection. Supported work includes both development of a device and integration of the POCT with healthcare monitoring/delivery systems (e.g., utilizing linkages to mobile health/telemedicine tools to communicate results in real-time), and reducing knowledge and training needs for its use. After program implementation, the proposed technologies are expected to provide clear clinical utility at the point-of-need. To that end, supported activities should include end-user co-design as well as usability studies.

Investigators must explicitly consider affordability as one of the design criteria for technologies proposed in applications responding to this topic. Technologies should be sustainable and affordable by local providers (either low enough in cost to easily replace, easily replaceable parts/ease of repair, or durability).

Phase I Activities and Deliverables:

Offerors must propose to conduct activities that lead to the development of a working prototype point-of-care test: 

  • Using end-user co-design principles, develop the prototype diagnostic test, assay, method, technology and/or device (here onwards referred to as device/test) with the following characteristics:
    • Ease of use: the device/test must be suitable for use by local caregivers in its operation and maintenance.
    • Operable in locations with limited clinical infrastructure (i.e., design for use outside of laboratory settings).
    • Designed for use at the community level and in non-traditional healthcare settings.
  • Demonstrate a working relationship with the site(s) where the clinical validation study will take place.
  • Conduct studies to establish analytical performance (analytical sensitivity, specificity) and other performance characteristics as required (e.g., limit of detection, consistency, reproducibility).

NOTE: Phase I activities likely require a collaboration or partnership with a research group or medical facility that can provide relevant patient access. As such, the offeror should provide a letter of support from the partnering organization(s)  in the proposal to that end.

Phase II Activities and Deliverables:

Offerors must propose activities leading to the manufacturing and regulatory approval of the point-of-care test/kit, including but not limited to:

  • Establish GLP, GMP practices, and quality management systems.
  • Optimize and produce functional prototype, while adhering to good laboratory practices (GLP) and/or good manufacturing practices (GMP).
  • Evaluate usability, acceptability, and feasibility of deploying the device/test in both average-risk and high-risk populations, in comparison with controls where applicable. Devices/tests must be validated in studies sufficiently powered to make them relevant for different racial/ethnic groups.
  • Conduct pilot studies and benchmark the device/test with the standard of care detection/diagnosis (At this stage, thennewly developed technology should not guide any clinical decisions).
  • Produce enough devices for multi-site and multi-test evaluations, including sites in a resource-limited setting in the U.S. and/or an LMIC.
  • Develop a training plan for the end users, to help assure progression toward clinical utility and increase benefits from the validated device/test.
  • Report on the sustainability/durability and stability of the device/test.
  • Establish plans to seek exemption or approval from regulatory agencies and coverage for the device/test by the public/private insurance payers (e.g., insurance companies, CMS, ministries/departments of health, etc.).

Per SBIR policy, when there are special circumstances justifying the conduct of the proposed research outside the US within time and budget constraints (e.g. a high disease incidence that makes clinical validation more feasible and timely), agencies may approve performance of a portion of the SBIR R&D work outside of the US. In this case, applicants are required to include a statement in their applications on why these resources are not available in the US.

 

Receipt date: Friday, October 18, 2024, 5:00 p.m. ET

Apply for this topic on the Contract Proposal Submission (eCPS) website.

View the full PHS2025-1 Contract Solicitation.

If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. In the case of permitted digital reproduction, please credit the National Cancer Institute as the source and link to the original NCI product using the original product's title; e.g., “NIH/NCI 474 - Point of Care Technologies for GI Cancer Prevention and Early Detection was originally published by the National Cancer Institute.”

Email