To Comply With FDA, 23andMe Won’t Give New Customers Genetic Analysis

The personal genetics startup 23andMe announced this evening that it will stop giving new customers access to health reports tied to their genes, after being warned by the FDA over compliance issues.

It is not discontinuing sales, however, as we initially thought based on the company’s wording. 23andMe said it would “comply immediately with the U.S. Food and Drug Administration’s directive to discontinue consumer access to its health-related genetic tests during the ongoing regulatory review process.”

However, that doesn’t mean that it’s stopping sales of new kits. Rather, new customers will only receive “raw genetic data without interpretation.”

It’s a departure from the company’s response of two weeks ago, which was to continue selling the kits but stop advertising them.

Mountain View, Calif.-based 23andMe had publicly apologized for being slow to respond, after the FDA complained of delays, The agency threatened seizure, injunction and civil financial penalties.

23andMe said tonight that it will continue offering access to its more than 250 health reports for customers who bought kits before Nov. 22, when it received the warning letter.

The FDA wants 23andMe to wait for clearance as a medical device before it can offer diagnostics to customers. It is concerned about people acting on information they receive about their genetics, or getting false complacency if the company’s testing mistakenly clears someone from risk.

However, the agency doesn’t yet offer classifications for many things 23andMe promises to do, so it will likely be a long road ahead to actually comply.

Here’s the notice now posted on 23andMe’s site, and a press release: