DTC Genetic Risk Reports Back on Market

By Kayte Spector-Bagdady, JD, MBE & Michele Gornick, PhD, MA

On Thursday, April 6th, the FDA announced that it will allow the direct-to-consumer (DTC) genetic testing company 23andMe to market “Genetic Health Risk” (GHR) tests for 10 diseases or conditions including early-onset Alzheimer’s and Parkinson’s Diseases. This is in addition to 23andMe’s current offering of ancestry, wellness (e.g., lactose intolerance), trait (e.g., hair color), and autosomal recessive carrier screening (e.g., sickle cell anemia) test reports.

The decade since 23andMe entered the market has been a regulatory labyrinth of twists and turns. But what direction are we headed now?

The way we were

23andMe was a pioneer of the field, entering the DTC genetics market in 2007 with a product offering 13 health-related reports for $999. By December 2013, it was offering more than 250 reports; including carrier status, drug response, and over 100 GHRs. In response to a set of FDA Untitled Letters that went out in 2010, 23andMe filed for de novo 510(K) premarket clearance for some tests… but also concurrently marketed them in a national television and web campaign. Continue reading

TODAY, 4/10 at 5 PM! Health Law Workshop with Leo Beletsky

April 10, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the presentation: “America’s Favorite Antidote: Murder-By-Overdose in the Age of the Opioid Epidemic”

Leo Beletsky is Associate Professor of Law and Health Sciences with a joint appointment with the School of Law and Bouvé College of Health Sciences at Northeastern University. His expertise is on the use of law to advance public health. He utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases, and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes, and human rights of vulnerable groups. Professor Beletsky communicates this work to legal, scientific and mainstream audiences, including as a contributor to The Huffington Post.

Throughout his career, Beletsky has applied his skills and expertise in service to governmental agencies and non-governmental organizations, including UNAIDS, US Department of Justice, the City of New York and the Open Society Foundations. This involvement has focused on legal reform and programmatic efforts to better align law and policing with community health. His commitment to translating lessons learned between domestic and international settings has informed a portfolio of projects across the Americas (US and Mexico), Central and East Asia (China, Kyrgyzstan, and Tajikistan) and Eastern Europe (Russia and Ukraine).

Prior to joining the Northeastern community, Professor Beletsky was on the faculty of the Division of Global Public Health at the University of California, San Diego School of Medicine, where he retains an adjunct appointment. He received his undergraduate training in geography from Vassar College and Oxford University, a master’s in public health from Brown University, his law degree from Temple University School of Law, and his post-doctoral training at the Yale University Center for Interdisciplinary Research on AIDS. He is a member of the New York State Bar.