DNA Double Helix --- Image by © Jacob Halaska/Monsoon/Photolibrary/Corbis
In early May, national pharmacy chain Walgreens indefinitely delayed sales of an at home genetic test kit after the U.S. Food and Drug Administration said that kit had not been proven safe or effective, and that further inquiry was needed to determine whether it fell into a category of medical device that requires FDA regulation. (The kit itself, manufactured by Pathway Genomics, was to sell for $20, though subsequent lab tests were expected to cost between $79 to $249.) Now the FDA has decided that at-home genetic test kits are indeed medical devices, and as such do require regulation.
Several genetic test manufacturers — including 23andMe, NaviGenics and Pathway Genomics — received letters from the FDA, which were published online this past Friday.
Critics of as-yet unproven at-home DNA tests — some of which claim to assess users’ risk for some 70 different diseases including types of cancer — suggest that they overstep existing knowledge about the role of genes in many diseases, and could potentially drive consumers to make serious medical decisions based on insufficient science. While many manufacturers have already said they will cooperate with the FDA, some also continue to argue that people have a right to their genetic information and that the FDA shouldn’t block that access, the L.A. Times health blog reports.
Yet at least one test manufacturer, Iceland’s DeCode, said they would actually embrace greater FDA scrutiny. As president of research Kari Stefansson told Businessweek:
“I welcome this because there is always a nagging little doubt and I want someone like the FDA to tell me we meet the standard… “Those less qualified may retreat… This may well change the mix.”