Thanks to a heads-up from the United States government, Walgreen’s will no longer be selling a controversial new over-the-counter genetic test kit, at least for the foreseeable future. The retail giant had plans to begin selling the kits on May 14, but U.S. regulators have made it clear that the product has not been properly reviewed by the Food & Drug Administration (FDA), as required by law.
Pathway Genomics, the company responsible for the gene test kits, has been marketing them as home-use saliva collection kits, which can be mailed in to provide customers with information regarding their risks for developing certain diseases, as well response to certain drugs, and the likelihood of passing genetic conditions on to offspring. However, the FDA has no record of verifying these claims, or clearing the product for use. Should Pathway dispute the need for FDA approval, they would first have to prove why that is so.
It remains unknown whether the FDA will directly attempt to block the sale of the test kits. Up to now, they have been available via the internet. Company spokesman Robert Blodgett said in an email to Bloomberg.com on May 12 that Pathway is in “continuing discussion with the FDA about the regulation of personal genomic information.”
Walgreen’s will not offer the Pathway genetic test kit for sale until FDA approval of the product is given.