On Thursday June 23, 2011, the FDA will be holding a public meeting to gather information on how to utilize ultra high throughput genomic sequencing technologies in clinical diagnostic applications.

In particular, the FDA is looking for input on "validation methodologies, materials, and bioinformatics approaches needed to address unique analytical validation requirements of ultra high throughput sequencing based molecular diagnostics and confirm the sequencing quality and the accuracy of the tests." The purpose of the meeting is to allow the FDA to promote the utilization of new and safe technology in the clinical setting.

The meeting will be held at the FDA White Oak Campus in Silver Spring, MD. Registration is open for those who are interested in attending the meeting in-person, or viewing a live webcast of the meeting.

For full information and to register for the in-person meeting or live webcast, click here:

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm255327.htm

In a February 23, 2011 letter to the Food and Drug Administration (FDA), the American Medical Association (AMA), called for genetic testing to be conducted under the guidance of qualified healthcare professionals such as genetic counselors, as well as FDA regulation of direct to consumer genetic tests.

“Without the benefit of proper medical counseling, patients may spend money on direct to consumer genetic tests needlessly or misinterpret the results of the tests, causing them to make unnecessary or unhealthy lifestyle changes,” said AMA Chair Ardis D. Hoven, MD. “While genetic testing can be a valuable tool to aid in diagnostic and therapeutic decisions, it should be done under the guidance of a physician, genetic counselor, or other genetics specialist. These health professionals are best prepared to help patients understand the results and the limitations of the tests, and what type of action should occur based on the results.”

The AMA's letter and full press release can be found here: 
http://www.ama-assn.org/ama/pub/news/news/genetic-testing-qualified-professionals.shtml

A task force is currently working to develop NSGC's Position Statement on Direct to Consumer Genetic Testing. NSGC's Position Statement on the Regulation of Genetic Testing, which was revised and adopted in 2010, can be found here:
http://www.nsgc.org/Advocacy/PositionStatements/tabid/107/Default.aspx#TestReg

Welcome to the NSGC Public Policy Bulletin Board! 

On this board you will find information about public policy issues of interest to genetic counselors and healthcare providers.  Feel free to comment and check back often!