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The developer of the test, Pathway Genomics, said Tuesday it would sell its product through Walgreens starting Friday. While similar tests have been sold over the Internet for more than two years, this would be the first such test sold through drugstores, making such testing more accessible.
That appeared to catch the attention of the F.D.A. In a letter to Pathway that was written Monday but made public late Wednesday, the agency suggested that Pathway’s test needed regulatory approval before it could be sold.
Walgreens then said in a statement that it would hold off selling the test “until we have further clarity on this matter.”
The F.D.A. is also looking at the legality of similar direct-to-consumer genetic tests, an agency official said.
Pathway’s test scans an individual’s DNA to provide information on the person’s risk of getting about two dozen diseases. It also looks at how a person might react to...