A Blueprint Proposal for Companion Diagnostic Comparability
A highlight of the FDA-AACR-ASCO Complexities in Personalized Medicine: Harmonizing Companion Diagnostics across a Class of Targeted Therapies workshop was the unveiling of a blueprint proposal developed by four pharmaceutical companies (Bristol-Myers Squibb Company, Merck & Co. Inc., AstraZeneca PLC, and Genentech, Inc.) and two diagnostic companies (Agilent Technologies, Inc./Dako Corp and Roche/Ventana Medical Systems, Inc.). The proposed study would help build an evidence base for PD-1/PD-L1 companion diagnostic characterization for non-small cell lung cancer in the pre-approval stage, such that once the tests are approved, the information generated can lay the groundwork for post-approval studies that will help inform patients, physicians, pathologists, and others on how best to use the test results to determine treatment decisions.
Read the Blueprint Proposal.
During the workshop the blueprint development team solicited input and feedback from interested parties. Read the feedback on the blueprint from
The blueprint team has considered the feedback received.
Read the team's combined response to both groups.
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