It's hard out there for a rule-flouting, heavily financed disruptor. If it's not government regulators, then it's "frivolous lawsuits," amirite? This time, it's a class action lawsuit filed in California accusing 23andMe of "falsely and misleadingly" advertising their $99 genetic tests. The complaint, which asks for at least $5 million, also says the tests are "not supported by any scientific evidence."

The timing of the complaint will no doubt spawn more outrage about silly government safety precautions.

The lawsuit was filed days after the FDA issued a warning letter to 23andMe for not finishing studies of its Saliva Collection Kit and Personal Genome Service five years after the company began marketing. In the letter, the FDA said "we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded..."

The agency's concern was that the tests and television ads would lead users to self-medicate based on unverified data. As epidemiologist and professor Cecile Janssens put it: "The FDA does not mind if people would like to know what their DNA sequence is, but it is concerned about the interpretation of that data by 23andMe."

That expansive marketing sans regulation is also noted in the suit:

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 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 indicators for the PGS, and initiated new marketing campaigns, including television advertisements in violation of the Federal Food, Drug and Cosmetic Act ("FDA Act").

In a letter to customers, 23andMe CEO Anne Wojcicki, the wife (as far as we know) of Google cofounder Segrey Brin, called the FDA "an important partner."

The company, which is backed by both Google Ventures and Brin personally, has stopped radio, TV, and online ads for 23andMe, but "has continued to sell its at-home testing kits," reports CNET.

Casey v 23andMe by jeff_roberts881