Transcript of
Genetic Testing Webinar

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On November 6, 2006, Genetic Alliance hosted a webinar to discuss the FDA draft guidances on genetic testing. Representatives of government, research, clinical care, industry and laboratories, including Mara Aspinall, Kathy Hudson, David Mongillo, Mike Watson, and Janet Woodcock participated. To review the major points each panelist presented, click here. While many questions were addressed during the webinar, time did not permit panelists to address all questions. To view questions generated during the webinar with answers supplied by panelists after the event, click here.

A transcript of questions and answers presented during the webinar follows.

Q by Sharon from attendees: What is the benefit to using the test developer to interpret the results? Does this impede access to the results for immediate use and medical decision-making? What is the overlap between FDA and medical decision-making, the role of the peer-reviewed literature process and clinical practice, what role does that play in terms of interpreting the tests and incorporating them?

Click to view answer from Dr. Woodcock

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