SAN DIEGO (CN) - A California company is selling a bogus $99 DNA saliva test that it falsely claims can identify 240 health conditions and risks, a class action claims in Federal Court.
Lead plaintiff Lisa Casey sued 23andMe Inc., a Delaware corporation based in Mountain View, Calif.
Casey claims the company - apparently named for the 23 human chromosomes - "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."
The lawsuit continues: "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.
"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."
People who buy the contraption are instructed to spit into a container and send it to the defendant, which allegedly analyzes the spit to calculate the person's risk for diseases such as coronary heart disease and rheumatoid arthritis.
The defendants' ads include false claims that users can "learn hundreds of things about your health, ... find out if your children are at risk for inherited conditions ... [and] arm your doctor with information on how you might respond to certain medications," according to the complaint.
Casey claims the so-called DNA tests are a sham, and provide no real insight into consumers' health or genetic risk factors.
Casey claims the FDA has weighed in on the company: that "after more than 14 face-to-face meetings, hundreds of email messages, and dozens of written communications between defendant and FDA concerning the public health consequences of inaccurate results from the PGS device, FDA has concluded, '...even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses,'" according to the lawsuit.
Casey seeks class certification and damages for unfair and deceptive trade, false advertising and unjust enrichment. She claims the defendant has been pushing its product for more than five years without being able to back up its claims.
She is represented by Mark Ankcorn.
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