No Gene Test At Walgreens Just Yet
If you were hoping to be the first on your block to stroll down to the drugstore for a personalized inventory of genes that could affect your health, you'll have to wait a little longer.
In a reversal, Walgreens drugstores won't be offering a battery of tests from a company called Pathway Genomics after all. The tests, whose full cost would range from about $100 to $300 depending on the number of genes covered, was to go on sale Friday.
The chain decided against selling the non-prescription product after the Food and Drug Administration informed the test maker that its genetic health report sure looked like something that should be vetted by the agency first.
Walgreens wants to wait until there's more "clarity" on the regulatory status of the tests, the Chicago Tribune reports.
In a bit of bureaucratic understatement, the FDA said it couldn't find any evidence in its files that the test kit had been reviewed and would "appreciate a response within 15 days" to its letter telling the company the product appears to be an unapproved medical device.
"We give them a chance to respond and tell us why do you think that this is, in fact, actually a legal product," Dr. Alberto Gutierrez, FDA's director of diagnostic testing, told the Associated Press.
For its part, Pathway is talking with the FDA about the regulation of such genetic tests, the New York Times reports. Other gene tests like Pathway's are available for sale on the Internet. And a Utah company has been selling paternity tests in drugstores since 2007.