WASHINGTON -- Genetic testing company 23andMe is facing a class action lawsuit alleging that the Silicon Valley startup misled customers with advertising for its personalized DNA test kit.
The test is marketed as a tool to help users predict their risk of developing various diseases.Food and Drug Administration (FDA) ordered 23andMe to halt sales of its personalized test, saying the company has failed to show that the technology is supported by science.
23andMe sells its $99 test online. Customers receive a small tube in the mail, which they return to the company with a saliva sample for DNA analysis. The company claims the analysis provides insight into users' ancestry and future health risks, including 240 conditions and diseases.
The lawsuit by San Diego resident Lisa Casey alleges that the test results are "meaningless," and that 23andMe uses false and misleading advertising to promote its services to U.S. consumers. The lawsuit seeks at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of U.S. customers are entitled to damages from the company.
Elsewhere, the complaint notes that 23andMe compiles customers' genetic information which it then markets to scientists for research. 23andMe has acknowledged that it hopes to pool the information from millions of customers to eventually create databases that can be mined for medical research.
"It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database," said Mark Ankcorn, a San Diego attorney who filed the lawsuit on behalf of Casey. Ankcorn said he was contacted Monday by an attorney representing 23andMe.
"I anticipate they are going to fight it and use every available resource they have to deny the claims," Ankcorn said.
A spokeswoman for Mountain View, Calif.-based 23andMe said in a statement Tuesday that it would not comment on legal matters. The company said it stopped advertisements via TV, radio and online last week. But the company's test kit is still prominently displayed on its website. When asked if the product is still being sold the spokeswoman declined to provide further comment.
The FDA's Nov. 22 warning letter to company CEO Anne Wojcicki noted that the personal test kits were improperly marketed for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response” and as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” including heart disease and breast cancer.
The FDA said some of the kits’ intended uses are “particularly concerning,” because the tests could have life-altering health consequences that could result from false positive or false negative tests. Examples of concern included testing for the BRCA gene variations linked to breast and ovarian cancer, or tests that look at whether people are too sensitive to the blood thinner warfarin and could put their lives at risk by taking it.23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.