23andme: The Business and Ethics of Personal Genetics Testing

Abstract

This case study is written to teach about genetic testing, privacy, and the future of applied genomic research. The case is especially useful for instructors in healthcare policy, healthcare politics, and NIH-mandated courses in the responsible conduct of research (RCR).In November 2013, the U.S. Food and Drug Administration (FDA) stopped 23andMe, a personal genetic testing company, from continuing to provide customers with disease risk information. The case describes the company’s background and operations as a provider of direct-to-consumer (DTC) testing for genetically linked diseases, behavioral traits, and familial lineage, with a focus throughout on issues of health policy and medical ethics. Several significant ethical and health policy issues are raised by the case. First, the ownership of genetic information is presently up in the air, with disputes over patents on gene sequences and questions about the degree of control that individuals can exercise over biological materials removed from their bodies. Second, is it the responsibility of the government (namely the FDA) to protect consumers from possibly misleading health information, or does such protection prevent people from learning useful probabilities and making behavioral adjustments that improve their health? Third, the case is structured to enable discussion of patient rights, specifically whether there is a right to not learn of disease predispositions.