The FDA has ordered 23andMe to immediately stop selling its DNA-testing kit, saying in a letter released today that the product is being marketed without “marketing clearance or approval.”
The $99 Saliva Collection Kit and Personal Genome Service (PGS) — which is meant to let users know whether they’re at risk of disease — was developed by the Silicon Valley company that counts Google Ventures among its backers, and was founded by Anne Wojcicki, wife of Google co-founder Sergey Brin.
The letter from the Food and Drug Administration says 23andMe has not adequately addressed its questions after much back-and-forth between the two parties. The agency said it’s “concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work. ”
In an emailed statement this morning, 23andMe said: “We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
The FDA order is just the latest regulatory headache for the Mountain View company. Three years ago, the Government Accountability Office said 23andMe and another Silicon Valley company, Navigenics, peddled information that was “misleading and of little or no practical use,” the Mercury News’ Steve Johnson reported. The tests by the companies were said to be too limited to be of worth.
Photo of 23andMe CEO Anne Wojcicki by Dai Sugano/Mercury News archives