Walgreens said late Wednesday that it would postpone selling a personal genetic test through its drugstores after the Food and Drug Administration challenged the legality of the test.
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 certain drugs and whether he or she carries mutations that could cause diseases in offspring.
Pathway, a privately held company in San Diego, said it was “continuing discussions with the F.D.A. about the regulation of personal genomic information.”
Such tests have long raised regulatory issues. One question is whether the tests are medical diagnostics or simply provide consumer information. The F.D.A. seems to be deciding that these are medical tests, in that they might influence the choice of a drug or perhaps cause a couple to terminate a pregnancy.
Even if they are medical tests, there is a question of whether they need approval. The F.D.A. typically does not require approval of tests that are performed by a single laboratory, as opposed to a test kit that is sold to hospitals and doctors’ offices. Pathway considers its test such a laboratory-developed test.
The F.D.A., in its letter, gives the company an opportunity to argue that its test does not need regulatory approval.
Alberto Gutierrez, the director of the F.D.A.’s office of in vitro diagnostics, said in an interview Tuesday that the agency sent letters last fall to a number of companies selling genetic tests directly to consumers, asking them to explain their tests and their business models. He would not identify the companies or say whether any action had been taken.
Navigenics, which sells a personal genomics test similar to that offered by Pathway, said it received an inquiry from the F.D.A. in May 2009 and met with the agency two months later. Navigenics said it believed it was in compliance with regulations.
The company 23andMe, probably the best-known purveyor of such a test, declined to comment on whether it had been contacted by the agency.
Dr. Gutierrez said the companies had different business models, making it difficult to clearly state which tests needed F.D.A. approval. But the saliva collection kit Pathway plans to sell through Walgreens seems to be a clearer case of one that does.
“Once you take a collection device and you are marketing through a drugstore, it is very easy for me to say whether something would fall under our policy,” he said.
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