Genetic Oversight: The Next Steps
AACC Audioconference
March 19, 2008
2:00 p.m. – 3:30 p.m.

Genetic oversight is once more the “buzz” in Washington as concerns about the accuracy and value of certain genetic tests, as well as the potential harms that could result from their misuse, have legislators and consumers pushing for new regulatory safeguards. The United States Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) are responding by broadening federal oversight in this area. Join in the 90-minute audioconference and learn what changes in genetic oversight are under way.

You’ll also learn what changes may be on the horizon. The United States Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Genetics, Health and Society recently released a report, which calls for greater private-public cooperation and oversight of genetic testing, including the expansion of Clinical Laboratory Improvement Amendments (CLIA) proficiency testing. This report may serve as the basis for future Department of Congressional action. Come learn what proposals are on the table and what they mean for your laboratory.

During this must-attend program, you’ll learn:

• How the FDA and CMS currently regulate genetic testing
• The latest on the In Vitro Diagnostic Multivariate Index Assays (IVDMIA) guidance and ASR Q&A
• What CMS is doing to strengthen genetic testing oversight
• What changes Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is recommending and their potential impact on genetic testing