Once again, FDA is meeting to discuss direct-to-consumer genetic tests, reports Genomics Law Report's Dan Vorhaus. In one month, the regulatory body's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will hold a public meeting to discuss the scientific issues surrounding DTC tests that make medical claims, Vorhaus says. The panel will investigate the risks and benefits of making such tests available to the public without a prescription, the different types of tests and how they could all be regulated, and the type of science that should be required to back up these tests' claims. "The meeting is a tacit acknowledgment by the FDA that the agency needs to continue to gather data and viewpoints about DTC genetic tests, along with the unique opportunities and challenges they present, separately from its ongoing efforts at LDT regulation," Vorhaus says. The public can submit comments to FDA until February 23, and can apply to make an oral presentation at the meeting until February 15.
Feb 10, 2011