​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 bot​h groups.

​Back to the Complexities in Personalized Medicine Workshop page.​