In the wake of the letter it received from the US Food and Drug Administration at the end of November, direct-to-consumer genetic testing company 23andMe is facing a class-action lawsuit.
The lawsuit, brought by Lisa Casey of San Diego, alleges that 23andMe "falsely and misleadingly advertises their Saliva Collection Kit/Personal Genome Service 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 suit, which seeks some $5 million, refers to the FDA letter.
The FDA letter said that the company had failed to adequately address some of the agency's concerns regarding the validity of the test and it instructed the company to stop marketing its test until the agency gives it authorization.
23andMe has halted its television, radio, and online ads to comply with the FDA request, though it noted to the Wall Street Journal that some may still air as it takes time to fully remove them. The Journal notes that at least one ad ran on the Travel Channel over the weekend suggesting the PGS as a gift idea.
HT: Law 360