Public Workshop: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices

June 14, 2017 (All day) to June 15, 2017 (All day)

1201 Pennsylvania Avenue, NW, Washington, DC


Over the last several years, FDA as well as others in the scientific community have co-sponsored several workshops aimed at advancing the discussion around biomarker qualification. Of particular importance are the analytical factors that must be considered when assessing the robustness and reliability of a biomarker assay used to qualify a biomarker. Under the leadership of the Critical Path Institute (C-Path), the Biomarker Assay Collaborative Evidentiary Considerations Writing Group has developed a draft framework outlining key criteria and best practices for biomarker assay performance expectations and validation. On June 14-15, 2017, The Duke-Margolis Center for Health Policy convened a two-day public workshop that served as a forum for broader input and feedback on this framework, with the goal of creating alignment on the evidentiary considerations for the analytical validation of biomarker assay.

Commenting on White Paper

As a follow up to the workshop, we have posted an updated draft of the white paper and framework as well as an Excel spreadsheet for including your comments and edits. Both documents are attached below. We ask that you please submit your comments by August 31, 2017. The working/writing group will consider carefully all comments provided by August 31 and develop a revised white paper for distribution/publication by the end of the year.  

Instructions for commenting in the spreadsheet are as follows:

  1. Please enter commenter's name in cell B1.
  2. Please enter line number range from the paper in column A.
  3. Please enter text from the paper as necessary to understand the comments in column B.
  4. Please enter text edits (highlight deletions, enclose insertions or rewritten sections in quotation marks) in column C.
  5. Please enter clarifying questions, suggestions, comments, etc. in Column D.
  6. Save the spreadsheet in the format CPATH_PTC_Comments_Username.xlsx.
  7. Email the spreadsheet to

If you have any questions, please do not hesitate to reach out to and

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