Cutting edge companies often walk a tightrope between regulators trying to keep their technologies under control and marketers trying to push them out to consumers as fast as possible.
That's where a Silicon Valley company named 23andMe is today. The Mountain View firm has been hawking genetic tests for you to take at home. You spit into a receptacle and ship your saliva back to the company so it can analyze your DNA for a mere $99. Eventually you get a readout detailing your genetic susceptibility to hundreds of diseases.
At least, that used to be the case. At the end of November, regulators at the Food and Drug Administration instructed the firm to shut down its genetic analysis service, declaring — with plenty of justification — that the company's marketing claims were running well beyond what was valid, or legal. The service fell within the legal definition of a medical diagnostic device, the agency said, and demanded data demonstrating the tests' technical validity. It warned 23andMe to ratchet back its marketing claims for the service, which it said requires agency approval before it can be sold to consumers — “as FDA has explained to you on numerous occasions,” the agency said.
The company will still send customers their raw genetic data and an analysis of what it says about their “ancestry,” but it has stopped issuing disease-risk analyses until it gets right with the FDA. Customers who ordered their tests on or after the date of the FDA's warning letter, Nov. 22, can get a refund.
Personal genetic testing has been building toward a craze for some time, as evidence mounts that certain genes or mutations can affect individuals' health profiles. Consumer interest often spikes with news events: Anne Wojcicki, the founder and CEO of 23andMe, says inquiries poured into her office in May, after actress Angelina Jolie disclosed that she'd undergone a precautionary double mastectomy upon learning she carried a gene that predisposed her to breast cancer.