|23andMe has stopped advertising its Personal Genome Service after an FDA warning.--Courtesy of 23andMe|
23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.
According to Reuters, the company has pulled all of its TV, online and radio ads for Personal Genome Service, a saliva-based test that provides patients with information on gene mutations, health risks and drug responses. The ads remain on 23andMe's YouTube page.
The move is unlikely to placate the FDA, which has asked the company to stop selling PGS altogether. 23andMe never secured agency approval for any of the test's intended uses, and, after 5 years of marketing and a few neglected applications, the FDA fired off a warning letter on Nov. 22 taking the company to task for ignoring regulators and demanding the test come off the market.
Last week, CEO Anne Wojcicki acknowledged that 23andMe had fallen "behind schedule" in its interactions with the FDA but gave no indication that the company would halt PGS sales, instead suggesting some sort of compromise with the agency. "This is new territory both for 23andMe and the FDA," she wrote in a blog post, and the company maintains that its product is not for diagnostic use but is instead "intended for research and educational purposes only."
The FDA, however, doesn't see anything so novel about PGS. The agency believes 23andMe's product is a medical device as defined by federal law, and thus it must endure all the regulatory rigors required of any other diagnostic product. In its letter, the agency warned that PGS's unverified results could spur patients to take drastic measures like undergo elective surgery or alter their drug regimens.
23andMe has said repeatedly that it stands by the data it returns to costumers.
- read the Reuters story