23andMe Faces Class-Action Suit

The complaint was filed days after a scathing FDA letter to the Google-backed firm

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A California woman filed a class action suit against 23andMe last week, days after the FDA released a scathing open letter criticizing the DNA-testing service for operating without approval.

Lisa Casey’s complaint, filed in a California court, is seeking at least $5 million in damages from 23andMe for allegedly making misleading claims about the tests’ ability to provide genetic information about conditions like breast cancer and diabetes, Gigaom reports. The complaint alleges the test results are “not supported by any scientific evidence.”

The damages sought includes a $99 refund for “tens or hundreds of thousands” of people who purchased the test.

The FDA requested the Google-backed firm stop marketing and selling its product last month unless it can provide evidence that the results are reliable.

[Gigaom]

2 comments
lifesciencesnow
lifesciencesnow

Some of the specific questions that need to be considered are: Should direct-to-consumer genetic tests be regulated as the practice of medicine? As a medical device? As personal health information? What intellectual property rights issues are raised by this case?

We recently published two articles addressing the opposing sides of this issue: http://lifesciencesnow.com/category/genetics/

We'll also be hosting a complimentary web-debate on the issue next Thursday: http://reaction.dbr.com/rs/vm.ashx?ct=24F76F1DD1E10AEDC1D180ABDB2B901DDFBE7BB3D38714DD4CF371647BF8D90DDD78031

GeneSherpas
GeneSherpas

I love it. How come you didn't note this when you named them Invention of the Year??? I spoke about it.

www.thegenesherpa.blogspot.com