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FDA Inquiry Halts Walgreens Sales of “Do It Yourself” Gene Test

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Deerfield, IL based Walgreen Co. has decided not to sell a controversial “gene kit” after the U.S. Food and Drug Administration said the device needs agency approval.

Pathway Genomics, of San Diego, CA, markets its Genetic Health Report directly to consumers, encouraging them to use the test results to modify their health regime to live a healthier, longer life. According to the company website, the test reveals a user’s genetic predisposition for more than 70 diseases and conditions, drug responses and pre-pregnancy carrier status. Among the test’s list of disease results are Alzheimer’s, breast cancer, diabetes, obesity and coronary artery disease.

The deputy director of Patient Safety and Product Quality for the FDA’s Center for Devices and Radiological Health, James Woods, sent a letter to the gene kit manufacturer’s founder and CEO, James Plante on Monday stating that the agency could not find the FDA clearance or approval number for the Genetic Health Report. He asked the company to submit the documentation or the reason they considered the product exempt.

“It has come to our attention that you are currently marketing the Pathway Genomics Genetic Health Report, a home-use saliva collection kit, intended to report customary and personal genetic health disposition results for more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health) information from which one can modify their health regime to live a healthier, longer life,” Woods said.

The kit was to sell in stores for between $20 and $30. The directions then required the consumer to collect a saliva sample for DNA and mail it to the laboratory. Test results were to cost between $79 and $249, depending on the consumers testing plan selection.

“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 Co., the leading U.S drugstore chain, said in a statement.

According to the Los Angeles Times, the gene kit was to hit Walgreens store shelves first on Friday and CVS stores in August. Gene test critics worry that consumers will misinterpret the significance of the results and use them to make healthcare decisions.

“The claims have limitations based on existing science, and consumers should not be making important medical and lifestyle decisions based on these tests without first consulting a health-care professional,” said FDA spokesperson Karen Riley.

DNA testing kits have been available online. The FDA did not act before because mainly physicians used the test, instead of mass marketed in consumer retail stores.

"It is reckless," said Hank Greely, director of Stanford University’s Center for Law and the Biosciences told The Washington Post. "Information is powerful, but misunderstood information can be powerfully bad."

The FDA letter asked for Pathway’s response within fifteen days.