23andMe, the most high-profile direct-to-consumer genetic testing company, relaunched its health-related genetic tests almost 2 years after the FDA cracked down on the company. The company has received FDA authorization for direct-to-consumer genetic tests that provide information about “carrier status” for 36 diseases, a small subset of the testing they were offering before the company received a warning letter from the FDA in 2013. Prof. Patti Zettler weighed in on this development for BuzzFeedNews’ article “DNA-Testing Startup 23andMe Is Making A Comeback” noting ““Hopefully now that 23andMe has gone through this process with the FDA for the carrier status tests, a pathway has been blazed . . . Both the FDA and [genetic testing] companies now have a model they can look to to see how it’s been done before.”
Patricia J. Zettler is an associate professor at Georgia State University College of Law this fall and was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.