Tag Archives: regulatory

Was the FDA Right to Shut Down 23andMe’s Marketing?

My opinion: the FDA was right to act in November by asking 23andMe to stop marketing  its personal genome service.  Now, don’t get me wrong, I have been rooting for 23andMe to succeed at what they are doing in the … Continue reading






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FDA Tells 23andMe to Stop Marketing: Death Knell for DTC Genomics 1.0?

The FDA on Friday published a letter  addressed to 23andMe’s CEO, Anne Wojcicki, telling the company to cease marketing it’s Saliva Collection Kit and Personal Genome Service (PGS). In the letter, Alberto Gutierrez, Director of the Office of In vitro … Continue reading






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DTC Genomic Testing—Policy Perspective in Science Magazine

Today’s Science magazine included a policy perspective on regulating Direct-to-Consumer genetic and genomic tests written by university ethics scholars.  In this article, the authors do a nice job of reviewing recent regulatory actions around DTC genomic testing, particularly in the … Continue reading






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More Genetic Testing in the News

It’s all over the news today–the GAO reports that Direct-To-Consumer companies are providing poor-quality services with deceptive marketing.  It is not the technologies that the companies that were investigated used to determine the genetic profiles of the subjects that are … Continue reading






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Matching Wits with Cancer

An article and a report spurred my thinking about the complexness of the cancer cell phenotype today.  Art Levinson, the long-time CEO and now Chairman of Genentech, wrote an editorial in the 9 April 2010 issue of Science supporting changes … Continue reading






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FDA Finalizes Bayesian Guidance: Good News!

The United States Food and Drug Administration has been considering whether to allow the use of Bayesian statistic in the design and analysis of clinical trials for several years.  Happily, in my opinion, the FDA recently finalized its decision to … Continue reading






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