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FDA Workshop to Gather Perspectives on Genetic Testing

On March 2, the U.S. Food and Drug Administration will hold an all-day workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results” as part of the president’s Precision Medicine Initiative (PMI). The purpose of this public workshop is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results.

The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, with an emphasis on the type(s) and amount of evidence available to interpret the results for medical purposes, how those results should be returned, and what information is needed to understand the results in the event that they could effectively aid in medical decision making.

Case studies to guide the discussion are available here. Written comments to the docket are also encouraged by March 31, 2016.