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Walgreens to Sell At-Home Genetics Tests to the FDA's Dismay

by Amar Toor on May 12, 2010 at 05:10 PM

Pathway genetics tests Genetics are kind of like Mexican food; if you happen to have good ones, your life can be sublime. If you're not so lucky, though, things can get ugly. And as doctors have become more aware of the critical role that genes play in determining a person's likelihood of developing breast cancer, obesity or Alzheimer's, genetic testing has become increasingly common in diagnostic labs and hospitals -- and, most recently, in the home.

Although many websites currently offer genetic tests to online consumers, the Sun-Times reports that Walgreens will soon become the first traditional, brick-and-mortar retailer to directly market the tests to customers. The at-home tests will allow users to take their own saliva samples, and return them to a lab to obtain results. The test kits will reportedly cost anywhere from $19.99 to $30 a piece, but consumers will have to pay significantly more to actually get results; a 'pre-pregnancy planning' or health condition test will cost you $179, while drug-response lab results will be priced at $79.

The FDA, however, is none too pleased about Walgreens' decision, and is thinking about issuing a warning to Pathway Genomics of San Diego, which manufactures the test. If issued, the warning would require Pathway to obtain FDA approval before placing the product on the consumer market. The FDA has never had to regulate genetics tests before, since they've traditionally been used within the confines of laboratories, and have thus been placed under the regulatory domain of the Centers for Medicare and Medicaid Services. The agency may also crack down on sites that sell the tests online, for much the same reason.

Walgreens, for its part, says it's given Pathway's products the same "due diligence" that it administers to all of its over-the-counter test products, including at-home pregnancy or paternity tests. Pathway Genomics CEO Jim Plante said in a statement that his company would "be happy to share with the FDA any data that is requested." Still, he reiterated, "We're still going to sell the kits at Walgreens because at this point, we're not aware of any reason we are unable to." Well Jim, there is that little thing about your product not being federally approved, which gives rise to the possibility that you're marketing a completely false item that may return invalid results. But hey, no biggie, right? [From: Chicago Sun-Times]

Tags: FDA, FdaApproval, food and drug administration, FoodAndDrugAdministration, genetics, genetictesting, health, healthcare, medical, pathwaygenomics, science, testing, testing lab, TestingLab, top

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