The Center for Law, Health and Society represents the culmination of research, educational and community outreach initiatives developed in the health law field at Georgia State University. For more information about the center, visit clhs.law.gsu.edu.

Prof. Zettler weighs in on 23andMe’s genetic test comeback

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zettler final23andMe, 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.

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