The FDA threw a wrench into 23andMe's genetic testing business late last year when it ordered the company to halt sales of its DNA analysis kit. 23andMe complied with that directive in December, and it's now providing an update as it works to push through the FDA's regulatory process. Unfortunately, four months after the agency first dropped the hammer, it seems 23andMe hasn't made much in the way of progress. "All 23andMe customers who purchased on or after November 22nd, 2013, still do not have access to health results, nor will they in the immediate future," the company said in a blog post today. 23andMe is apparently negotiating with the FDA to allow the release of a small "subset" of health reports, but it's not able to provide any timetable for when that might occur.
"Customers who purchase 23andMe now should do so with the understanding that health results are not available to them."
In the meantime, 23andMe clearly doesn't want anyone to be misled. The company states flatly: "Customers who purchase 23andMe now should do so with the understanding that health results are not available to them." Several times, the latest post underlines the fact that there's no timeline on when customers should expect to start receiving their results again. "Getting this right is important for everyone involved. We will continue to be as transparent about the process as we can, and give updates when appropriate." Whether 23andMe can survive the scrutiny of a frustrated FDA and emerge unchanged remains an open question, and it appears the answer won't come soon.