FDA Warning Causes Walgreens’ Halt On Genetic Testing Kit

May 14th, 2010 - 1:26 am ICT by Angela Kaye Mason

May 13 (THAINDIAN NEWS) Walgreens recently announced their intention to be the first store to sell genetic testing kits which would give people advanced notice as to whether or not they are genetically likely to get cancer, Alzheimer’s, obesity, and other ailments which are believed to be genetically linked.

The announcement prompted a warning from the US Food and Drug Administration, however, which was aimed at the manufacturer of the kit, Pathway Genomics of San Diego. Pathway was told that they must first gain the approval of the FDA before they could sell the product. The FDA may also crack down on other manufacturers who are selling similar products on the internet as well, according to the Chicago Times. In a statement to CNN from the FDA, it was said “Pathway Genomics has moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect a sample. These kits have not been proven safe, effective or accurate and patients could be making medical decisions based on data from a test that hasn’t been validated by the FDA.”

After the warning issued by the FDA, Walgreens has decided not to sell the genetic testing kits for now. Although the company had planned to start stocking their shelves on thousands of store tomorrow (Friday) Walgreens has postponed the sale of these kits. “In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Jim Cohn, a Walgreens spokesman. In an effort, perhaps, to protect customers as well as protect themselves from possible lawsuits, Walgreens has elected to postpone the sales.

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