23andMe halts product marketing
In the wake of a Warning Letter it received from the FDA on Nov. 22, genetic test maker 23andMe has put a halt to marketing its products, Reuters reports. The company has stopped its advertising on television, radio and online.
23andMe founder Anne Wojcicki noted in a blog post on Nov. 26 that the company had kept up a dialogue with the FDA since 2008 concerning its DNA test. However, in its letter, the FDA wrote that both of the company's applications for clearance (one in July of last year and one in September) had been withdrawn because it had not responded to requests for further information.
Wojcicki commented that the company had received feedback on the submissions and was behind in its responses. "We stand behind the data we return to customers," she said, "but we recognize that the FDA needs to be convinced of the quality of our data as well."