Walgreens shelves plans to sell genetic test

[The Straight Story]

Walgreens shelves plans to sell genetic test
FDA investigating home test kit and its supplier


Walgreens late Wednesday reversed a decision to carry genetic test kits in its stores after the U.S. Food and Drug Administration began an investigation of the supplier and product.

Deerfield-based Walgreen Co. had planned to begin stocking thousands of stores nationwide with the Pathway Genomic home test kit on Friday. Walgreens' decision was announced after the FDA released an enforcement letter sent to San Diego-based Pathway Genomics, giving it 15 days to respond to the agency's request for information regarding its controversial genetic home test kit.
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"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 a letter dated Monday and released Wednesday, FDA Deputy Director for Patient Safety and Product Quality James Woods said the FDA has been "unable to identify any Food and Drug Administration clearance or approval number" for the product.

The kit, sold under the brand name Insight, comes with a vial and a shipping envelope. Buyers send a sample of saliva to a Pathway Genomics laboratory and receive a genetic health report online.

http://www.chicagotribune.com/business/ct-biz-0513-walgreen-genetics-20100512,0,1951117.story