Dr. Gerald Zon’s latest blog post, dated January 6, 2014, and published by TriLink BioTechnologies of San Diego, focuses on the controversial subject of direct-to-consumer (DTC) genetic testing. Dr. Zon shares some personal history, beginning in 2009, of dealing with Navigenics, the first provider of direct-to-consumer (DTC) SNP-based genetic testing and medical counseling. He then discusses 23andMe, a company that has been a lightning rod of controversy in the area of DTC genetic testing and received a “bombshell” November 2013 letter from the FDA calling on the company to stop marketing its testing kit until it received proper authorization. D. Zon also noted the FDA’s November issuance of marketing authorization for the first high-throughput (next-generation) genomic sequencer (Illumina’s MiSeqDx), which will allow development and use of innumerable new genome-based tests, as described in a December 19, 2013 New England Journal of Medicine Perspective piece by Francis Collins, M.D., Ph.D., and Margaret Hamburg, M.D. Dr. Zon further mentioned the “upbeat “Consumer Genetics Conference,” held in September 2013 to emphasize the swirl of developments and debate in this key arena. According to Dr. Zon, Navigenics began selling its genetic testing services in 2008 based on SNP analysis to assess risk for a variety of common health conditions. In July 2008, California health regulators sent cease-and-desist letters to Navigenics and 12 other genetic testing firms, including 23andMe. The state regulators asked the companies to prove a physician was involved in the ordering of each test and that state clinical laboratory licensing requirements were being fulfilled. Two months later, Navigenics and 23andMe received state licenses allowing the companies to continue to do business in California. Dr.
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