23andMe: Genetic Testing For Consumers (A)

To maximize their effectiveness, color cases should be printed in color. On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was marketed as a diagnostic and preventative tool and that it was subject to the agency's regulations for medical devices. Company co-founder Anne Wojcicki and chairman Andy Page carefully considered the potential impact of the FDA's letter on 23andMe's position in the industry and the sustainability of its operations.