Skip to Content
Cancer Diagnosis Program
Contact NExT
Show menu
Search this site
Last Updated: 11/29/17

Assay Harmonization Activities and Resources

The goal of assay harmonization is to ensure that clinical laboratory test results are equivalent no matter which clinical laboratory performs the test. When assays are not standardized or harmonized, a different numeric result may be obtained for the same clinical sample depending on the measurement procedure used. Variations in non-harmonized test results could lead to erroneous decisions made regarding a patient’s care if clinical guidelines for diagnosis or disease management are based on test results from a specific laboratory measurement procedure without consideration of that fact that various measurement procedures may exist.

The Cancer Diagnosis Program promotes assay harmonization efforts within the cancer research community by providing resources, including funding opportunities and literature with recommendations on harmonization needs and approaches.

Publications and Recommendations

EBV

EBV DNA in Plasma/Serum/Blood

In 2015, the Cancer Diagnosis Program convened a Workshop on Harmonization of EBV Testing for Nasopharyngeal Cancer, where experts in head and neck oncology and laboratory medicine addressed the limitations of currently available polymerase chain reaction-based EBV DNA quantitation assays and discussed strategies for advancing the development and appropriate clinical use of harmonized EBV DNA assays.

The workshop resulted in two publications accessible below:

  1. This article presents the key recommendations to direct future efforts in assay harmonization and validation. djx007.10.1016/j.ijrobp.2017.03.018.
  2. This article discussed the clinical utility of EBV DNA testing and issues that need to be considered for future studies aimed at informing clinical practice guidelines for EBV DNA.
    https://www.ncbi.nlm.nih.gov/pubmed/28721913

Funding Opportunity Announcements for Assay Harmonization

For additional FOAs, please see our funding opportunities page.

PAR-17-003

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

https://grants.nih.gov/grants/guide/pa-files/PAR-17-003.html

Posted date: October 4, 2016; Expiration date: October 29, 2019
Application receipt dates: February 28, 2017; July 11, 2017; February 27, 2018; July 11, 2018; October 26, 2018; February 27, 2019; July 11, 2019; October 28, 2019, by 5:00 PM local time of applicant organization.

Applications to this FOA should propose to clinically validate an existing assay using human specimens in a clinical laboratory into a molecular assay that can be used in a clinical trial for the treatment, prevention or control of cancer. However, projects that improve standardization or harmonization of assay performance among laboratories are also highly encouraged, and these types of projects may involve continued efforts in assay optimization and ensuring concordance of assay results from different laboratories. Therefore, these types of applications may be viewed as exceptions to the requirement that analytical validation should have been completed by the time Revision applications are submitted.

This grant provides supplement funding for investigators who currently have an active R01 grant.

Award budget is limited to $150,000 in direct costs per year.

CDP contact: Dr. Kelly Kim, 240-276-7811, kimke@mail.nih.gov

Assay Validation For High Quality Markers For NCI-Supported Clinical Trials: PAR-17-317 (UH2/UH3 Clinical Trial Not Allowed)

Reissue of PAR-15-095. Posted date: October 13, 2017; Expiration date: October 9, 2020.
Application receipt dates: February 14, 2018; July 10, 2018; October 8, 2018; February 13, 2019; July 10, 2019; October 8, 2019; February 13, 2020; July 10, 2020; October 8, 2020, by 5:00 PM local time of applicant organization.

This Funding Opportunity Announcement (FOA) is a phased initiative to improve the development of molecular diagnostics for use in NCI-supported clinical trials in 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.

CDP contact: Dr. Kelly Kim, 240-276-7811, kimke@mail.nih.gov

View the full FOA on Grants.NIH.Gov.

Assay Validation For High Quality Markers For NCI-Supported Clinical Trials: PAR-15-096 (UH3 Clinical Trials Not Allowed)

Reissue of PAR-15-096. Posted date: October 13, 2017; Expiration date: October 9, 2020.
Application receipt dates: February 14, 2018; July 10, 2018; October 8, 2018; February 13, 2019; July 10, 2019; October 8, 2019; February 13, 2020; July 10, 2020; October 8, 2020, by 5:00 PM local time of applicant organization.

Assays proposed for this FOA may be used to validate existing assays for use in other 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. Clinical laboratory staff, technical and other needs must be an integral part of the application. 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.

CDP contact: Dr. Kelly Kim, 240-276-7811, kimke@mail.nih.gov

View the full FOA on Grants.NIH.Gov.