The U.S. Food and Drug Administration (FDA) issued a warning letter in late November 2013 to 23andMe, Inc., the company that marketed a home “Saliva Collection Kit and Personal Genome Service” designed to provide a DNA analysis from the sample and inform consumers whether they are at risk of developing certain diseases. According to FDA, the product is a medical device “because it is intended for use in the diagnosis of disease or other conditions” and requires the agency’s pre-market approval under the Food, Drug, and Cosmetic Act. FDA also expressed concern with false positive or negative assessments and the potential for “patients relying on such tests [to] begin to self-manage their treatments through dose changes or [abandonment of ] certain therapies.” Four other personal- genomics companies also received warnings on November 22 that they require preapproval for their products.
According to a news source, 23andMe has discontinued providing the service to new customers, but will maintain access to the health-related reports already generated for customers before the warning letter issued. Those who purchased the products before November 22 will also appar- ently continue to receive their results. Saying that the company remains committed to helping people access their genetic data, co-founder and CEO Ann Wojcicki said, “Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.” Meanwhile, less than a week after the letter was sent, a putative consumer-fraud class action was filed against 23andMe. Additional details about the litiga- tion appear elsewhere in this Bulletin. See Law360, December 2, 2013; genomeweb.com, December 6, 2013.