Case | HBS Case Collection | January 2014 (Revised April 2014)

23andMe: Genetic Testing for Consumers (A)

by John A. Quelch and Margaret L. Rodriguez

Abstract

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.

Keywords: marketing; public health; strategy; genome testing; health care; genetics; ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States;

Citation:

Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised April 2014.)