OpportunityTitle: Revision Applications for Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (U10)
AdditionalInformationOnEligibility: 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.
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 has essentially completed analytical validation in human samples and whose importance is well justified for development into a clinical assay. Analytical validation of assays for these markers should be sufficiently advanced when the application is submitted so that clinical validation may be achieved with little further analytical validation needed. Revisions may support acquisition of specimens from retrospective or prospective studies from NCI-supported or other clinical trials. 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 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.
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GrantorContactText: NIH OER Webmaster&lt;br/&gt;FBOWebmaster@OD.NIH.GOV&lt;br/&gt;