With personal genetic testing kits available for sale in stores and online, the FDA recently announced that it would regulate the kits as medical devices and require companies to prove the tests are valid and accurate.
Even though it was only last month that the FDA prevented the sale of genetic testing kits in Walgreens, the agency seems to have been moving slowly to take a position regarding kit regulation. Things changed last week when the FDA sent letters to five companies marketing genetic tests (three of which sell personal test kits online) or test components informing them that their products were, in fact, medical devices.
Much of the brouhaha in the news has centered on the public’s ability to consume the information provided by the kits responsibly. While this is clearly a concern, I’m not entirely sure that this is a legitimate impediment to test kit sale. People do, after all, have a right to their own personal medical information.
What perhaps should be regulated, however, is how that information is presented to the people reading the results, the quality of the device itself, its potential to do any harm, and the information disseminated in marketing efforts.
If you’re wondering why the FDA is only now jumping into the fray, you’re not alone. After all, even if you can’t buy genetic test kits at Walgreens, anyone with Internet access can still buy them online. According to USA Today, the tipping point came when marketing efforts went from medically benign uses such as paternity testing to identifying the potential for disease.
23andMe, for example, advertises that the information helps people “live well at any age,” showing an image of an aged man and adolescent girl. I would have expected marketing to have been aimed at adults, but the company highlights information that is relevant to children.
Have you had parents schedule a visit to discuss the results of personal genetic testing for their child? At around $500 a pop, it’s not something everyone can afford, but I’m curious as to how test availability might affect how often children are tested.