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The Honolulu Advertiser
Posted on: Thursday, May 13, 2010

Walgreens won't sell gene test kits

By Bruce Japsen and Sandra M. Jones
Chicago Tribune

CHICAGO Walgreens yesterday 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.

Walgreen Co. had planned to begin stocking thousands of stores nationwide with the Pathway Genomic home test kit tomorrow. 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.

"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 yesterday, 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.

"If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us the basis for the determination," Wood said in his letter to Pathway Genomics.

The home tests are supposed to assess the risk of dozens of health conditions, including Alzheimer's disease, breast cancer and heart disease. Pathway officials have said they believe the test is in compliance with federal regulations. They said the kits were not medical devices and were not intended for use in diagnoses, but to provide information to people to make lifestyle choices.

"Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines," Pathway said in a statement issued yesterday in response to the FDA's inquiry. "Our laboratory is federally (Clinical Laboratory Improvement Amendments) certified and state-licensed. 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."