Is Walgreens the Tipping Point for Personal Genomics Regulation?
At first blush, this might appear to be nothing more than a creative product partnership between a fledgling personal genomics company and a giant drugstore chain. As it turns out, there are early indications that the Pathway/Walgreens partnership could turn out to be a tipping point in the regulation of personal genomics. With that in mind, and since this post is slightly longer than usual, here’s a quick roadmap for the remainder of this article: I. Aisle 8: Spit Kits. Basic details about Pathway Genomics’ products and its partnership with Walgreens. II. Location, Location, Location. Why this time it is the location of the product that matters, and not its price or its content. III. Enter the Gatekeepers. Though this is not the first time concerns have been voiced about DTC genetic testing, the direct comments from an FDA official are particularly striking, and suggest that these concerns may be finally be ready to produce a regulatory response. IV. The Regulation of DTC Genetic Test
