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Walgreens won't sell over-the-counter genetic test after FDA raises questions

By Rob Stein
Washington Post Staff Writer
Thursday, May 13, 2010; A02

The nation's largest drugstore chain backed out Wednesday of plans to sell a saliva test that promised to scan a customer's DNA to assess his or her risk for breast cancer, heart attacks and a host of other diseases.

Walgreens had planned to offer the Pathway Genomics test at more than 6,000 of its 7,500 stores nationwide beginning Friday, but it reversed course after the Food and Drug Administration questioned whether the test could be sold legally without the agency's authorization.

"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.

The Washington Post reported Tuesday about plans by Pathway and Walgreens to start selling the over-the-counter test. Pathway said its Insight test could evaluate a propensity for developing medical conditions such as Alzheimer's disease, diabetes and obesity; the likelihood of parenting a baby with cystic fibrosis, Tay-Sachs disease and other genetic disorders; and the possible reaction to caffeine, cholesterol-lowering drugs, blood thinners and other medications.

Other companies have been selling on the Internet tests that can analyze genes for a person's risk of some diseases, and genetic tests for paternity and ancestry have been widely available in stores. But the plan by Pathway Genomics of San Diego represented the boldest move yet to bring personalized genomic science to the mass market.

It was welcomed by those who hope that deciphering the genetic code will launch a new era in biomedical science. But it raised objections from those who worried that the average consumer would have problems interpreting the results, leading to dangerous complacency about some diseases or unnecessary alarm, as well as opening the door to privacy violations, genetic discrimination and other problems.

An FDA official told The Post on Monday that the test required the agency's authorization because it involved consumers collecting their own DNA. Company officials disputed that, saying the test was exempt from FDA oversight because the testing was being done at its own lab.

But in a letter to Pathway released by the agency late Wednesday, the FDA's James L. Woods notified the company that the test "appears to meet the definition of a device" under federal law, therefore making it subject to the agency's review.

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

In a statement Wednesday, Pathway said: "We respect and understand Walgreens' decision, and we are communicating with the FDA" about the test.

Experts have long called for the FDA to regulate the burgeoning field of genetic testing more aggressively, and some speculated that the agency's move could mark a change in policy.

"Walgreens is clearly acting in the interest of its customers by postponing the introduction of the Pathway product," said Sharon Terry of the Genetic Alliance, an advocacy and research group. The "FDA, for its part, must be the guardian of safety and efficacy, all the while encouraging innovation and the benefits that genetics can bring to medicine."

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