Taking a peek into our genes isn’t something easily accomplished, and that is where the Google-backed 23andMe genetic testing service came in. For $99, anyone could send in their sample and receive the results a short while later. In recent days, the company was slapped with an order from the FDA to stop selling its kits, and a handful of days later, customers have filed a class-action lawsuit against the company.
The lawsuit was filed in the past week by customer Lisa Casey, who hails from San Diego and says that she paid for the testing service and subsequently received her results. The FDA’s warning against the company has prompted her to file the lawsuit in representation of the “ten or hundreds of thousands” of other customers who likewise paid for the service. In the filing, the lawsuit is seeking a minimum of $5 million.
The reason is both misleading and false advertisement, which comes in light of the FDA’s orders and warning letter. The advertisements, says the lawsuit, falsely states that the test can give relevant details about various possible genetically-indicated health concerns, such as proclivities towards certain types of cancer and a predisposition towards, for example, developing diabetes.
Under the FDA banhammer, 23andMe is required to pull all of its advertisements, something that is still a work-in-progress at the moment. The concern, in part at least, according the FDA, is that the information provided by 23andMe could result in customers seeking preventative treatments that are ultimately unnecessary, such as getting a preventative mastectomy if the results indicate that one could be prone to breast cancer.
On November 25, the company’s CEO and co-founder Anne Wojcicki issued a statement in response to the FDA’s actions, saying that the company believes “that genetic information can lead to healthier lives,” and that it works “extensively” with its lab partner to make sure that the results provided are accurate. According to Wojcicki, 23andMe stands by its results, but must convince the FDA now.
Of course, not all customers feel they have been mislead or are otherwise displeased with 23andMe. After the FDA’s warning was made public, journalist Shaheen Pasha went public with news that her genetic testing results showed a higher than average risk for an autoimmune disorder, among them being Hashimoto’s disease, something she says was diagnosed with weeks before receiving her results after years of going to doctors. Had she had the results sooner, she wonders, would doctors have been more likely to consider the condition and find the source of her ailments sooner?
The lawsuit was filed on November 27.