Walgreen Co. yesterday reversed its decision to sell a home genetic-testing kit that is not approved by the FDA after the agency pursued the test’s manufacturer to determine why they assumed they do not require approval.
“I was surprised that Walgreens had the audacity to even try to sell these,” says Dr. Whelan. “I would think the FDA would be right on their heels. I don’t see what good could possibly come of a home genetic test.”
Dr. Ross agrees: “There aren’t that many diseases linked to particular gene expressions, and such complex genetic testing requires a professional genetic counselor to be worthwhile, so scattershot testing like this is unlikely to be helpful. And it’s very likely to cause unnecessary anxiety among people who try to interpret the results themselves. ACSH’s advice is: Don’t use these tests.”
“The bottom line is, while Walgreens may have decided not to sell these for now, the technology is still available on the Internet, and it’s still unregulated,” says Stier. “We’re not big fans of lots of regulation, but we think that consumers should be more skeptical of these products until we have a better grasp on the science.”