Genetic testing company 23andMe, which last week suspended the sale of its health-related genetic tests, is now facing a class-action lawsuit in California over its marketing claims. The lawsuit alleges that the results of its Personal Genome Service (PGS) are 'meaningless' and that 23andMe used 'false and misleading' advertising to promote it.
The lawsuit, filed by San Diego resident Lisa Casey, asks for at least US $5 million in damages under various Californian state laws on behalf of 'tens or hundreds of thousands' of 23andMe customers for the amount they had paid for the test. It alleges that the company 'furthered a common scheme to induce members of the public to purchase the PGS by means of misleading, deceptive and unfair representations'.
23andMe first introduced the PGS to the market in 2007 and sold access to an array of information on more than 260 genetic conditions and traits, from a person's carrier status to disease risk, and drug response. Its health-related genetic test informed customers of their susceptibility to conditions including diabetes, coronary heart disease and lactose intolerance.
The lawsuit claims, however, that 'the [health test] results it provides are not supported by any scientific evidence'. It states that 23andMe 'has marketed and sold PGS to consumers for years without any analytical or clinical data to support the device's efficiency'. The complaint also takes issue with 23andMe's goals for research.
It notes that 23andMe stores customers' genetic data - which it then markets to scientists for research. 'It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database', Mark Ankcorn, the lawyer who filed the lawsuit on behalf of Casey, told NBC.
The lawsuit was filed in the district court of California last week, and came two days after the Food and Drug Administration (FDA) ordered 23andMe to 'immediately discontinue' sales of its PGS, saying that 23andMe had failed to provide documentation to support its marketing claims (reported in BioNews 733).
In its warning letter, the agency said that 23andMe had failed to obtain approval for marketing the kits and service. It also said the company had not proven that the analysis and results of the PGS were safe, accurate and reliable.
The FDA's letter raised concerns that false test results for breast and ovarian cancer could cause customers to take unnecessary action, such as intensive screening or even prophylactic breast removal. The lawsuit states that the plaintiff and customers had suffered injury and loss as a result of 23andMe's 'false and misleading statements', but did not provide further details.
Representatives for 23andMe countered that the PGS is meant to help people to better understand their health and not to provide a medical diagnosis. In its terms of service, 23andMe says that 'only a small percentage' areas of DNA analysis in the PGS are known to be related to human traits or health conditions.
Furthermore, it tells customers: 'You should not assume that any information we may be able to provide to you, whether now or as genetic research advances, will be welcome or positive'.
The company withdrew its TV, online and print advertisements and, on Thursday, said that it would stop selling health-related information until its test undergoes regulatory review. 23andMe will continue to sell its ancestry service and access to raw data, without health-related interpretations, and has indicated that it will resume the service if it receives regulatory approval.
23andMe has emphasised that the FDA's concerns were based on the fact it had not received what it considers sufficient proof of the test's accuracy. 'It's not that the data isn't accurate. It's that we didn’t complete the FDA's substantiation studies on time', 23andMe spokesperson Catherine Afarian told VentureBeat. 23andMe founder and chief executive Anne Wojcick has said that she 'stands behind the data'.