Newswise — Journalists covering the recent announcement by Pathway Genomics that it will sell health-related genetic marker tests to consumers—and the subsequent decision by Walgreens to postpone sales of the kits pending clarification of their legal status—are invited to interview Berman Institute experts Joan Scott or Gail Javitt.
The drugstore chain recently announced that plans to sell the so-called “spit kit” are now on hold after the Food and Drug Administration (FDA) sent a letter to Pathway questioning whether the company had received FDA authorization to market the device.
Pathway Genomics markets its Insight test as a way for consumers to find out if they have a genetic predisposition that puts them at increased risk for cancer, heart attacks and other disorders. The kits, priced at around $30, were supposed to debut in 6,000 Walgreens locations today.
Scott—director of the Genetics and Public Policy Center (GPPC), research scientist at the Berman Institute of Bioethics, and a certified genetic counselor—can address general scientific and ethical issues surrounding genetic testing, and direct-to-consumer testing in particular.
Javitt—formerly the law and policy director at GPPC and currently a research scholar at the Berman Institute—has taught on the topics of food and drug law, as well as genetics and law. She has also written extensively on direct-to-consumer marketing of genetic testing and FDA regulation of biotechnology, and she has particular expertise in FDA regulation of in vitro diagnostics and laboratory developed tests.
For more information:Joan Scott, M.S., C.G.S.: http://www.dnapolicy.org/about.staff.php?action=detail&bios_id=9Gail Javitt, J.D., M.P.H.: http://www.bioethicsinstitute.org/mshome/?id=92
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