Tuesday, December 03, 2013

Class Action Law Suit Filed Against 23andMe

Forbes is reporting that a class action law suit has been filed against the DNA testing company 23andMe:

Class Action Law Suit Filed Against 23andMe

Here's the filing:

United States District Court for the Southern District Of California, 27 November 2013, Lisa Casey V. 23andMe

The suit alleges:
"1. This proposed class action alleges that 23andMe, Inc.(“Defendant”) falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service (“PGS”) as providing “health reports on 240+ conditions and traits”, “drug response”, “carrier status”, among other things, when there is no analytical or clinical validation for the PGS for its advertised uses."

"2. In addition, Defendant uses the information it collects from the DNA tests consumers pay to take to generate databases and statistical information that it then markets to other sources and the scientific community in general, even though the test results are meaningless."

"3. Despite Defendant’s failure to receive marketing authorization or approval from the Food and Drug Administration (“FDA”), Defendant has slowly increased its list of indications for the PGS, and initiated new marketing campaigns, including television advertisements in violation of the Federal Food, Drug and Cosmetic Act (“FDC Act”)."
Much of this I said in my prior post, FDA Ordered Genetic Testing Co. 23andMe To Stop Selling Home Test Kit. I didn't know that 23andMe was turning around and selling consumers' data! Is that what item 2 says? This reminds me of Facebook, where a company lures consumers into divulging personal information then turns around and sells it. I wonder who is buying it.

Why doesn't 23andMe just validate it? If they are so sure their service provides meaningful, accurate, health-promoting data, why don't they conduct the studies and submit the results to gain approval? According to the FDA, more than 5 years after they began marketing, they still had not completed studies and had not even started others! No drug company could get away with that.

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