The National Cancer Institute is offering a grant to enhance the validation of molecular diagnostics crucial for cancer treatment, control, or prevention. This grant focuses on validating prognostic, predictive, or response markers for treatment in cancer trials. Applicants must have a validated assay working in human samples with significant justification for clinical development. The grant includes an initial phase for analytical assay validation followed by a phase for clinical validation using samples from NCI-supported trials. The grant emphasizes collaboration among scientific, clinical, statistical, and laboratory staff. Proposals should not focus on assessing clinical utility but on developing assays for potential utility in future trials. Deadline for applications: Oct 6, 2017.
Opportunity ID: 271789
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-095 |
| Funding Opportunity Title: | Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (UH2/UH3) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.394 — Cancer Detection and Diagnosis Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 21, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Oct 06, 2017 |
| Current Closing Date for Applications: | Oct 06, 2017 |
| Archive Date: | Nov 06, 2017 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Special district governments State governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Native American tribal governments (Federally recognized) Independent school districts For profit organizations other than small businesses County governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) is to improve the development and validation of molecular diagnostics for the treatment, control, or prevention of cancer. This FOA includes, but is not limited to, the validation of prognostic, predictive or response markers for treatment and markers for cancer control or prevention trials. Applicants should have an assay that works in human samples and whose importance is well justified for development into a clinical assay. The UH2 phase of this FOA supports analytical validation of assays for these markers that must be achieved within two years before an assay may undergo clinical validation. The UH3 phase of this FOA supports the clinical validation of established assays for up to three years using specimens from retrospective or prospective studies from NCI-supported or other clinical trials. In both the UH2 and UH3 phases, clinical laboratory staff, technical and other needs must be an integral part of the application. Assays proposed for this FOA may be used to validate existing assays for use in other cancer clinical trials, observational studies or populations. Projects proposed for this FOA will require multi-disciplinary interaction and collaboration among scientific investigators, clinicians, statisticians and clinical laboratory scientists and staff. This FOA is not intended to support trials that assess the clinical utility of a marker/assay but is intended to develop assays to the point where their clinical utility could be assessed in other trials. Investigators responding to this FOA must address both UH2 and UH3 phases. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-15-095.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-C | FORMS-C | PKG00212023 | Feb 26, 2015 | May 06, 2016 | View | |
| FORMS-D | Use for due dates on or after May 25, 2016 | PKG00223275 | Jun 08, 2016 | Oct 06, 2017 | View |
Package 1
Mandatory forms
271789 RR_SF424_2_0-2.0.pdf
271789 PHS398_ResearchPlan_2_0-2.0.pdf
271789 PHS398_CoverPageSupplement_2_0-2.0.pdf
271789 RR_Budget_1_3-1.3.pdf
271789 RR_KeyPersonExpanded_2_0-2.0.pdf
271789 RR_OtherProjectInfo_1_3-1.3.pdf
271789 PerformanceSite_2_0-2.0.pdf
Optional forms
271789 PlannedReport-1.0.pdf
271789 PHS398_CumulativeInclusionReport-1.0.pdf
271789 RR_SubawardBudget30_1_3-1.3.pdf
Package 2
Mandatory forms
271789 RR_SF424_2_0-2.0.pdf
271789 PHS398_CoverPageSupplement_3_0-3.0.pdf
271789 RR_OtherProjectInfo_1_3-1.3.pdf
271789 PerformanceSite_2_0-2.0.pdf
271789 RR_KeyPersonExpanded_2_0-2.0.pdf
271789 RR_Budget_1_3-1.3.pdf
271789 PHS398_ResearchPlan_3_0-3.0.pdf
Optional forms
271789 RR_SubawardBudget30_1_3-1.3.pdf
271789 PHS_Inclusion_Enrollment_Report-1.0.pdf
271789 PHS_AssignmentRequestForm-1.0.pdf
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