Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Detection, Diagnostic and Treatment Technologies for Global Health (UH2/UH3)

Notice Number: NOT-CA-14-055

Key Dates
Release Date:   September 12, 2014
Estimated Publication Date of Announcement:  Fall 2014
First Estimated Application Due Date: Spring 2015     
Earliest Estimated Award Date: September 2015    
Earliest Estimated Start Date: September 2015 

Related Announcements
None

Issued by
National Cancer Institute (NCI)

Purpose

The National Cancer Institute supports the development of cancer-relevant technologies that would be suitable for global health environments with limited resources. NCI is announcing its intent to reissue a Funding Opportunity Announcement (FOA) soliciting applications for the development of new technologies/devices and/or adaptation of existing technologies/devices for cancer detection/diagnosis and treatment to be tested and ultimately implemented in low- and low-middle-income countries (LMICs), as listed by World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).

The intent of this Notice is to provide potential applicants with lead time to start the process of forming teams, building collaborations, and planning responsive applications.  

The FOA is expected to be published in the Fall 2014, with an expected application due date in Spring 2015.

This FOA will utilize cooperative agreements with the UH2/UH3 activity code. Details of the planned FOA are provided below

Research Initiative Details

This FOA will be open to all qualified applicants with the appropriate expertise and capacity to conduct cancer-relevant technology development and/or adaptation and, ultimately, its validation for cancer detection/diagnosis and/or treatment in low resource global health settings.

Proposed projects need to consider the following:

1) Focus on cancer types that are treatable in low resources settings. Projects to be considered must be centered on a technology/device/assay development/adaptation addressing cancer(s) that is (are) treatable in the low-resource setting where the demonstration (UH3) stage of the project will take place. Note that the term, treatable, refers to the local context and the abilities of the local health system. In summary, proposed devices/assays must directly add value at the point-of-care.

2) Technologies/devices suitable for cancer detection/diagnosis or treatment in low resources settings. Applications in response to this FOA must propose to adapt, apply, engineer, and validate existing or emerging technologies or assays into a new generation of technologies and assays for detection, imaging, in vitro diagnosis, or treatment of cancers treatable in an LMIC.

  • Adaptation: Modification of an existing assay or device such that it can be used for the detection or treatment of cancer.
  • Engineering: Simplification or addition of new features to a device or assay to enable the device to operate outside a lab in an LMIC
  • Applying existing/emerging technologies not been previously used for cancer or used in LMICs.
  • Validation: Validate the analytical and clinical performance of the device or assay to detect or treat a specific cancer in an LMIC.

3) Required and desirable attributes of a technology/device/assay to be developed. Suitable technologies/devices/assays to be proposed for development/adaptation must be based on a working prototype or an existing device demonstrating a general feasibility of the proposed approaches. The demonstration of their usability for a chosen cancer is not a prerequisite for application. After the implementation, the proposed technologies/devices are expected to provide tools that are comparable to existing established technologies/devices/assays in clinical practice. However, they are additionally expected to be of low cost, portable, easy to operate by local workers in targeted LMICs, and fully functional under limited resource conditions.

4) Clinical validation trials in LMICs. All the projects must include plans for an appropriate trial to validate the use and benefits of the technology/device/assay and establish the device’s potential clinical utility in the targeted low-resource environments. The validation trials required for the second phase of the projects must be conducted in LMICs.

5) Multi-disciplinary teams. To address the goals of the upcoming FOA, investigators will have to assemble a collaborative research program with appropriate multidisciplinary expertise in: oncology, engineering, and global health. In addition, a business component will be required to address issues of manufacturing, regulatory approvals, dissemination, maintainability and sustainability of the technology/device/assay in the targeted LMIC.  These multidisciplinary teams are expected to be organized by institution(s) in the United States but must involve appropriate collaborative partnerships with institutions in LMICs for conducting the validation trials.

6) Two-phase projects. Initial cooperative agreement awards of up to two years will be granted for an exploratory (UH2) phase to demonstrate technical functionality and clinical potential in cancer-specific applications. The most promising projects will be selected for transition to the validation (UH3) phase of the award (for up to three years). The primary focus of the UH3 phase is to conduct appropriate validation trials in LMICs.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Paul Pearlman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5810
Email: paul.pearlman@nih.gov