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Walgreens postpones carrying Pathway Genomics genetic test kit

The chain's reversal comes after the FDA says it has no record of authorizing the product, which the maker says can be used to detect risks of getting such conditions as Alzheimer's or heart disease.

May 13, 2010|By Bruce Japsen and Sandra M. Jones

Reporting from Chicago — Walgreen Co. reversed a decision to carry genetic test kits in its stores after the U.S. Food and Drug Administration began looking into the supplier.

The drugstore chain, based in Deerfield, Ill., had planned to begin stocking its shelves Friday with the Pathway Genomics home test kit, which the manufacturer claimed could provide information on the risks of getting conditions such as Alzheimer's and heart disease, and also examine the likelihood of passing on health problems to children.

Walgreen's announcement Wednesday came shortly after the FDA released an enforcement letter sent to Pathway Genomics of San Diego, giving the company 15 days to respond to the agency's request for information regarding the product.

The FDA letter — dated May 10 but not made public until Wednesday — was signed James Woods, the agency's deputy director for patient safety and product quality. He wrote that the FDA had been "unable to identify any Food and Drug Administration clearance or approval number" for the product.

"If you do not believe that you are required to obtain FDA clearance or approval," Woods wrote, "please provide us for the basis for the determination."

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

The product has been available through online merchants. Walgreens would have been the first prominent retailer to carry it.

"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," Walgreen spokesman Jim Cohn said.

The product claims to assess the risk of dozens of health conditions, but some scientists and physicians had expressed concerns. Earlier this week, the National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."

Pathway officials have said that they believe the test is in compliance with federal regulations.

"Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines," the company said in a statement Wednesday. "We have provided the same personal genetic report to customers for the past year, and are continuing discussions with the FDA about the regulation of personal genomic information."

bjapsen@tribune.com

smjones@tribune.com

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