Soon, you may be able to pick up a genetic testing kit at your local drugstore. A San Diego company has made a deal to sell its new Insight test at Walgreens locations across the country, promising consumers a look at their risk for Alzheimer's, breast cancer, diabetes, and more. The Pathway Genomics kits sell for $20 to $30, with analysis costing between $79 and $249. There's just one problem: It might be illegal.
The FDA hasn't approved or even looked at the test. “We think this would be an illegally marketed device,” an agency official tells the Washington Post. “We don't know whether the test works, and whether patients are taking actions that could put them in jeopardy based on the test.” But Pathway's chief science officer isn't worried. “This test does not have FDA approval per se,” he says, but he's not sure it needs it, because consumers collect their own DNA samples.