Thursday, March 3, 2016

FDA Workshop on Return of Genetic Test Results (March 2, 2016)

On March 2, 2016, the FDA held a workshop on "Patient and Medical Professional Perspectives on the Return of Genetic Test Results."

The FDA workshop website is here.  At that website, you can access the agenda, videocast online, and eventually a transcript.  For coverage at Gray Sheet (subscription), here.

A few days earlier, the FDA held a workshop on next generation sequencing and cancer gene panels (here).

Many participants may have felt that most medical genetics has proceeded well for decades with no interference from the FDA regarding either molecular testing of germline variants (in general) or FDA supervision of reports for clinicians and patients.