FDA to look into at-home gene tests

On Friday the FDA acknowledged that it was reconsidering whether to permit pharmacies and drug stores to sell at-home genetic testing kits.

These kits give consumers some information which can help them to learn more about their approximate risk of certain inherited diseases, as well as future illnesses like cancer and heart disease and of unwanted drug interactions.

Although such kits are already sold online by companies like Navigenics and 23andME, the FDA only took notice of the issue when Walgreens announced a deal with Pathway Genomics to make the kits available at 6,000 of its stores. That agreement has been placed on hold pending the government’s investigation. Critics of the kits have harped on the possible dangers presented to patients who are given medical information, which might be inaccurate, in the absence of a doctor or other professional counselor.

New York has already passed laws prohibiting the sale of the kits in stores.

While ACSH's Dr. Gilbert Ross does not dismiss these concerns, he nonetheless asks: “When the first at-home pregnancy tests were offered to women — and that was not so long ago — did anyone suggest that women couldn’t handle the test results? Shouldn’t it be a personal choice whether or not a person gets such a test? The FDA’s role should be to rule on the accuracy of the tests. The horse, it would seem, is already out of the barn anyway, as the internet cannot be regulated.”