Walgreens announced yesterday that it will delay plans to sell a number of consumer genetic tests, developed by Pathway Genomics, after learning of concerns from the Food and Drug Administration (FDA). The agency sent Pathway a letter on Monday questioning whether the tests could be sold without the agency’s approval.
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Walgreens spokesman Jim Cohn, the Washington Post reported.
According to the newspaper, Pathway said in a statement late Wednesday, “We respect and understand Walgreens’s decision and we are communicating with the FDA about the Pathway Genomics Insight collection kit. Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines.”
The developments highlight the lack of clarity over regulation of direct-to-consumer genetic diagnostics. Other companies have sold similar tests over the internet, so it’s unclear why the FDA chose to intervene in this case. For both Pathway and other companies, such as 23andMe, consumers collect saliva samples themselves, and then the tests results are revealed via a specialized website. The dust-up isn’t the first for the direct-to-consumer genetics industry though–previous regulatory concerns have come from states, notably California and New York, rather than federal agencies.
According to the Post:
An FDA official told The Post on Monday that the test required the agency’s authorization because it involved consumers collecting their own DNA. Company officials disputed that, saying the test was exempt from FDA oversight because the testing was being done at its own lab.
But in a letter to Pathway released by the agency late Wednesday, the FDA’s James L. Woods notified the company that the test “appears to meet the definition of a device” under federal law, therefore making it subject to the agency’s review.