Earlier this summer, Pathway Genomics made a PR splash by announcing their intent to sell a DNA testing kit through Walgreen’s & CVS pharmacies that could help consumer’s predict diseases to which they might be genetically predisposed. The noise attracted the attention of the FDA which quickly stifled the idea. Now FDA officials are taking a much deeper look into direct-to-consumer testing kits, and the ramifications could affect an entire industry category.
Jeffrey Shuren, head of FDA’s medical devices division said he considers direct-to-consumer genetic tests “high risk” and that it could be difficult for direct-to-consumer tests to gain agency approval the way they are currently marketed.
Other diagnostic tests have made the successful leap to the drug store, including diabetes testing supplies, pregnancy kits, and fertility monitors. So now that Pathway Genomics has opened the floodgates, how involved with the FDA get?
