San Diego woman sues 23andMe over DNA test

by jeeg 4. December 2013 20:47

A San Diego County woman has filed a lawsuit seeking class-action status against 23andMe, alleging that the company knowingly misled consumers into thinking that its DNA test kits produce a reliable look at a person’s relative risk for hundreds of diseases and disorders.

Lisa Casey also alleges that the Mountain View-based company falsely led consumers to believe the same kits and accompanying DNA analysis could identify whether a person carries certain potentially problematic genes, and how well that individual might respond to various medications.

Casey is asking for at least $5 million in damages on behalf of 23andMe customers.

“There is no analytical or clinical validation for the (personal genome service) advertised by 23andMe,” Casey said in her claim, which was filed in U.S. District Court in San Diego.

She, her attorney — Mark Ankcorn of downtown San Diego — and 23andMe couldn’t be reached for comment Tuesday afternoon.

The case was filed Nov. 27, two days after the U.S. Food and Drug Administration ordered 23andMe to stop marketing its $99 direct-to-consumer DNA test kits and analysis service. The agency said the company had failed to obtain approval for marketing the kits and service. It also said the privately owned company, which is heavily funded by Google, had not proven that the kit and analysis are safe, accurate and reliable.

Customers of 23andMe provide a sample of their saliva. The company performs a partial genetic analysis on the saliva, looking for genes that could be involved in a wide range of health problems — from cancer to dementia to age-related macular degeneration. The company’s advertising materials say it can determine a person’s relative risk for about 240 health conditions and traits, as well as a person’s relative tolerance for some medications.

Representatives for 23andMe have admitted that the company has been slow to provide the FDA with all the requested information. They also said the popular, direct-to-consumer test kit is merely meant to help people understand their potential health problems and not to provide a medical diagnosis. (The company’s full response.)

The FDA found that explanation lacking. So did Casey, who said in the court papers that 23andMe “has marketed and sold (the kit and service) to consumers for years without any analytical or clinical data to support the device’s efficiency.”

She also said 23andMe “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.”

Gary Robbins, UT San Diego


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