The Future of Direct-to-Consumer Genetic Testing: Regulation and Innovation

January 13, 2015

Direct-to-consumer (“DTC”) genetic testing companies face regulation from numerous parties. The Food and Drug Administration has taken the lead role in the regulation of this industry. The Federal Trade Commission must make sure that consumers are not misled by unscrupulous marketing and false advertising. The Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments should ensure that genetic tests are analytically and clinically valid. State laws and federal statutes like the Genetic Information Discrimination Act address consumer privacy concerns. The recent Molecular Pathology v. Myriad Genetics, Inc. Supreme Court decision will shape the direction of DTC genetic testing patents. Case law is also influencing DTC genetic consumer protection. These various regulatory mechanisms must strike a balance between protecting DTC genetic test consumers without stifling important innovations in this industry.