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NIH/NCI 456– Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Only Direct-to-Phase II and Fast-Track proposals will be accepted. Phase I 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 $2,000,000 for up to 2 years

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


Summary

Cervical cancer is the fourth most common cancer in women. When pre-cancer or cancer is diagnosed early, cervical cancer is one of the most preventable or treatable forms of cancer. Cervical cancer has become a cancer that defines global health disparity populations based on inequities in the feasibility of delivering effective, but complex and costly screening programs based on cytology and colposcopic diagnosis in low-resource settings.  

Because of this, the World Health Organization (WHO) Cervical Cancer Elimination strategy calls for screening the majority of women with a high-performance HPV test twice in their lifetime. Realization of that goal using current commercial HPV tests is unlikely. To realize cervical cancer screening elimination goals in low-resource settings, it is essential that new tests can be performed and analyzed outside of traditional healthcare settings and are at a price point that is affordable to enable scalability. Fortunately, emerging test chemistries, including those based on isothermal amplification of HPV DNA, have shown significant promise for the design of highly accurate HPV diagnostics at a lower cost than existing tests. Recent developments in microfluidics, microfabrication, and hand-held computers further improve the prospects for adaptation of accurate, low-cost point-of-care versions of existing lab-based assays. 

The overarching goal of the work to be supported by this initiative is to bring new alternatives for HPV testing to the market that are, both in a form factor as well as price point, will enable self-testing programs to be established globally at point-of-care or near point-of-care. This topic is aligned with the Cancer Moonshot Blue Ribbon Panel recommendation to expand the use of proven cancer prevention and early detection strategies (G). 


Project Goals

Projects in response to this FOA should first develop a functioning prototype for a portable HPV diagnostic designed for near-patient use. Projects should establish initial clinical performance for the device using clinician-collected samples before moving to a larger prospective validation of the device using self-collected specimens. Applicants can propose modifying an existing device such that it can be used for HPV diagnostics at the point-of-need; simplify or add new features to a device to enable the device to operate outside a laboratory; and/or apply existing or emerging technologies that have not been previously used for HPV diagnostics. Supported work includes both the development of the device as well as approaches for simplifying sample preparation and reducing knowledge and training needs for its use.

Adaptation/test menu expansion of platforms developed for COVID-19 diagnostics, especially low-cost, portable Nucleic Acid Amplification Test (NAAT) tests, is encouraged as part of this solicitation.

After implementation, the proposed technologies/devices are expected to provide clear clinical utility at the point-of-need. To that end, supported activities should include end-user design and usability studies centered around minimally-trained health workers at the community level. The technology must comply with the applicable regulations and international standards/guidelines such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), WHO guidelines, FDA Investigational New Drug (IND), FDA Investigational Device Exemption (IDE), and local regulations at project sites outside the US.

Investigators must explicitly consider affordability and cost-effectiveness design criteria for technologies proposed in applications responding to this FOA. Considerations of cost and affordability must include any consumable products required to effectively perform the test. Technologies should be sustainable and affordable to local providers (either low enough in cost to easily replace, easily replaceable parts/ease of repair, or durability).

Note: This FOA focuses on the development of novel HPV diagnostic platforms and does not support the development of associated devices for self-collection and/or transport/storage of cervicovaginal specimens.

Phase I Activities and Deliverables:

  • Offerors must provide a letter of support from the partnering organization(s) in the proposal.
  • Using end-user design principles, develop the prototype diagnostic device with the following characteristics:
  • Ease of use: the device must be suitable for use by local caregivers with minimal training 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.
  • Intended for use with either provider or self-collected cervicovaginal specimens obtained with one of the current commercially available kits. Note: Showing that the test works only with provider collected specimen is not sufficient for this deliverable.
  • Demonstrate a working relationship with the site(s) where the clinical validation study will take place.
  • Conduct studies to establish analytical performance (e.g., analytical sensitivity, specificity) and other performance characteristics (e.g., limit of detection, consistency, reproducibility) with self-collected samples.
  • Conduct studies to evaluate and test user acceptability and feasibility in both average-risk and high-risk (e.g., women living with HIV) populations.
  • Conduct initial cross-validation with at least one of the current FDA-approved HPV testing assays to determine the clinical performance measures.

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:

  • Develop educational materials for interpretation of the test results and when to seek medical guidance. 
  • Develop a well-defined diagnostic device under GLP and/or GMP.
  • Perform manufacturing scale-up and production for multi-site and multi-test evaluations, including sites both in the US and at a site in a resource-limited setting.
  • Demonstrate the clinical sensitivity and specificity of the device for provider-collected and self-collected specimens by performing multi-site and multi-test evaluations.
  • Develop a training plan for healthcare delivery users to help assure progression toward clinical utility and benefit from the validated technology.
  • Report on the sustainability/durability of the device/assay.
  • Establish a strategy for FDA regulatory approval and insurance and/or CMS reimbursement.

 

Receipt date: November 14, 2023, 5:00 p.m. Eastern Standard Time

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

View the full PHS2024-1 Contract Solicitation.

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