Walgreens halts genetic test sales on FDA concerns

Walgreens halts genetic test sales on FDA concernsEarlier this week, Walgreens announced with great fanfare that it was selling a controversial over-the-counter genetics test. The drug store chain quickly changed its mind after the Food and Drug Administration objected, ending the bewildering episode as quickly as it started.

Testing your own DNA makes as much sense as do-it-yourself surgery or serving as your own lawyer. Experts argue that it is a spectacularly bad idea. Genetic results are often vague and raises many questions that can be best answered by a trained professional such as a genetics counselor. Moreover, scientists don't yet fully understand the genetic aspects of Alzheimer's disease and many other conditions.

Officials from the FDA are investigating whether the test's maker, Pathway Genomics of San Diego, Calif., was improperly marketing them, according to the Chicago Tribune. Walgreens is holding off on selling the tests until the FDA's concerns are resolved, media reports say. An FDA spokesperson could not be reached.

The test kits made by Pathway Genomics shows the market for DNA testing is expanding beyond settling the question of whether the mother on the "Maury Show" is telling the truth about the identity of her child's father. People also examine their DNA to learn about their ancestry. Scientists at the National Geographic Society are collecting DNA samples from people around the world to learn about the origins of man. Genetic tests like the one offered by Pathway Genomics are harder to find and do not come cheap.

Pathway Genomics planned to sell a $20-$30 "saliva collection kit" at Walgreens. Getting the results was more expensive, with costs ranging from $79 to $249 depending on the amount of testing involved. Rival 23andMe Inc., which counts Google and Genentech as investors, charges $429 to tell clients about their risk for certain diseases such as Cystic Fibrosis and Diabetes. Both Pathway Genomics and 23andMe Inc. did not respond to requests for comment as did Walgreens. CVS/Caremark, Walgreens biggest rival, also did not return a message.

"This was a change in the marketing for the testing rather than the science," Elizabeth Kearney, president of the National Society of Genetic Counselors, in an interview. "It's really important that people talk to someone like a genetics counselor to make sure that they are getting the right test done."

Sometimes, she says, counselors are able to tell whether someone is susceptible to certain diseases and conditions by taking a detailed family history, making a genetic test unnecessary. Technology for DNA testing continues to evolve. Results from a test done today may look differently in a few years as scientists better understand the human genome.

For its part, Pathway claims to be providing customers useful medical information.

"The value of knowing how genes play a role in our personal lives, and potentially the lives of our children, is critical for making well-informed health and wellness decisions," CEO Jim Plante said in a press release touting the Walgreens deal.
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