Cancer: Validation of Biomarker Assays from NIH Grants


Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01)

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as “assays”) to the clinic. Specifically, the focus of this FOA is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) for cancer detection, diagnosis, prognosis, monitoring, and prediction of response to treatment, as well as markers for cancer control and prevention. Research applications may support acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay.

This FOA is not intended to support early stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.


  • Pre-Application Submission: 30 days before application submission due date
  • Application Submission: 5:00 PM local time of applicant organization, Feb. 28, 2017; Jul. 11, 2017; Oct. 27, 2017; Feb. 27, 2018; Jul. 11, 2018; Oct. 26, 2018; Feb. 27, 2019; Jul. 11, 2019; Oct. 28, 2019



Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.