About Kayte

Kayte Spector-Bagdady is a Research Investigator in the Department of Obstetrics and Gynecology at the University of Michigan Medical School and also leads the Program in Research Ethics in the Center for Bioethics and Social Sciences in Medicine (CBSSM). Her current research explores informed consent to emerging technologies with a focus on reproduction and genetics. Kayte received her J.D. and M.Bioethics from the University of Pennsylvania Law School and School of Medicine respectively after graduating from Middlebury College. She completed a research fellowship in bioethics at CBSSM. She is a former drug and device attorney and Associate Director of the Presidential Commission for the study of Bioethical Issues.

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