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Last Updated: 08/30/17

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

PAR-15-095

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3)

https://grants.nih.gov/grants/guide/pa-files/PAR-15-095.html

Posted date: January 21, 2015; Expiration date: October 7, 2017
Application receipt dates: March 26, 2015; July 8, 2015; October 7, 2015; February 9, 2016; July 8, 2016; October 7, 2016; February 9, 2017; July 7, 2017; October 6, 2017, by 5:00 PM local time of applicant organization.

The UH2 phase of this FOA supports analytical validation of assays for these markers that must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this FOA supports clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials/studies. This FOA may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this FOA.

Applicants may request up to $275,000 direct costs for the entire UH2 phase and up to $250,000 direct costs for the UH3 phase per year.

CDP contact: Dr. Tracy Lively, 240-276-5944, Livelyt@mail.nih.gov

PAR-15-096

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3)

https://grants.nih.gov/grants/guide/pa-files/PAR-15-096.html

Posted date: January 21, 2015; Expiration Date: October 7, 2017
Application receipt dates: March 26, 2015; July 8, 2015; October 7, 2015; February 9, 2016; July 8, 2016; October 7, 2016; February 9, 2017; July 7, 2017; October 6, 2017, by 5:00 PM local time of applicant organization.

The UH3 mechanism supports the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This FOA may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this FOA will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists.

Applicants may request up to $250,000 direct costs per year for a maximum of 3 years.

CDP contact: Dr. Tracy Lively, 240-276-5944, Livelyt@mail.nih.gov