• Washington Post, Thursday, May 13, 2010 10:43 AM

Following a Food and Drug Administration inquiry, Walgreens says it is reversing a decision to sell a saliva test made by Pathway Genomics that promises to scan a customer's DNA to determine the risk for a host of diseases including breast cancer, diabetes and obesity, Rob Stein reports. It had planned to offer the product at more than 6,000 of its 7,500 stores starting tomorrow.

"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," says Walgreens spokesman Jim Cohn.

James L. Woods, the FDA's deputy director, patient safety & product quality, told Pathmark that its test "appears to meet the definition of a device" regulated under federal law and invited it to offer evidence that it is not subject to FDA clearance. Pathmark said that it understands Walgreen's action and is "communicating with the FDA."

Read the whole story at Washington Post »