Shortly before Thanksgiving, the Food and Drug Administration ordered that Google-backed 23andMe stop marketing its at-home genetic testing kits because the company had failed to get regulatory clearance for many of the product’s advertised uses. On Monday, the company announced it was abiding by that decision but hopes to work something out with the FDA, but has yet to tell any of its current customers what is going on with their kits. [More]
Alleging that the makers of the popular, Google-backed 23andMe at-home genetic testing kit are violating federal law by marketing the product for things like disease diagnosis without regulatory clearance, the FDA has ordered an immediate halt to sales of the kits. [More]
After scaring Walgreens out of the genetic-testing business, the FDA has now decided to crack down on the entire industry, and will be subjecting DNA tests to the same rules that it applies to medical devices such as blood-glucose meters.
While Walgreens may have voluntarily chosen not to sell home genetic testing kits in the face of an FDA investigation, its action has brought attention to the entire for-profit testing industry, and others may not have the luxury to quietly shut down on their own. A congressional committee is looking into the business, and could end up regulating the industry.
If you were, well, salivating at the idea of spitting into a test tube at your corner Walgreens and sending off for a list of diseases you’re at risk for, you may have to keep that drool in check for a while. The Food and Drug Administration is investigating the planned test kits, which were due to appear in stores later this month.
Afraid of their insurance getting jacked up or of employer discrimation, people who think they might be genetically predisposed to certain diseases are testing themselves with home DNA kits, hiding the results from their doctors, and harboring a potentially deadly secret. [NYT]