Thursday, May 13, 2010

Gene Test Won't Be Sold at Walgreens

You may have heard that drugstore chain Walgreens was planning on selling a new genetic health report kit that would determine customers' genetic health dispositions. It turns out that Walgreens has decided against offering the Pathway Genomics Genetic Health Report kit after the U.S. Food and Drug Administration (FDA) issued a letter of warning to Pathway Genomics this week. The letter, accessible here on the FDA's web site, suggests that the FDA has not provided clearance or approval for the genetic kit, as the Federal Food, Drug, and Cosmetic Act requires. You can read about Walgreens' change of heart on NPR's website ("No Gene Test at Walgreen's Just Yet," 5-13-2010).

The Pathway Genomics product qualifies as an in vitro diagnostic, or IVD. To get an overview of how the FDA regulates IVD, see this web page. To find out which home and lab tests have been approved or cleared by FDA, you can search the agency's IVD Over the Counter (OTC) Database. Also, don't forget that you can find additional government health resources in our guide.

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