23andMe Stops Selling Genetic Testing Kit
December 4, 2013

23andMe Stops Selling DNA Testing Kit

Brett Smith for redOrbit.com – Your Universe Online

According to a report from BBC News, genetic testing company 23andMe has stopped selling its at-home DNA testing kit. The move comes after the company, which is backed by Google, received an official warning from the Food and Drug Administration (FDA) last week that said it needed to discontinue sales of the kit.

Using human saliva samples, the kit is supposed to allow users to find out about their health risks based on their genetic information.

The discontinuation of the kit also comes after a class action lawsuit was filed in US district court in California last week. The lawsuit alleges the company’s advertisements are misleading.

Founded in 2006 by Anne Wojcicki, the recently separated wife of Google co-founder Sergy Brin, 23andMe had offered a DNA test kit for $99 that reportedly identifies an array of genetic markers for disease.

In its warning letter, the FDA said because the product “is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body,” it falls under a certain regulatory purview that has yet to be met.

In a statement, the Mountain View, California-based 23andMe said "we recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission."

In its letter, the FDA noted how certain test results, like a false positive for ovarian cancer, could have potentially disastrous results. Conversely, a false negative for ovarian cancer could provide a false sense of security.

The federal agency did note that 23andMe submitted applications in July and September of 2012 for some disease areas.

"However," the FDA said, "to date your company has failed to address the issues described during previous interactions with the Agency" or furnish requested supplemental information. Subsequently, the FDA said the former applications "are considered withdrawn."

The FDA added it was "diligently working" to help the company be in compliance and has spent considerable effort evaluating the intended uses of the testing kit, which has included numerous email exchanges, teleconferencing sessions and phone calls.

"However, 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," the FDA said.

“Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns,” Catherine Afarian, a spokeswoman for 23andMe, told Bloomberg News regarding the warning letter.

In November, Wojcicki told the New York Times that 23andMe had mapped the genotype of nearly 480,000 people over the last five years and she expected to "hit a million" sometime in the first quarter of 2014. She also told Fast Company that her company is aiming for 25 million subscribers.

"Once you get 25 million people, there's just a huge power of what types of discoveries you can make," she said in an interview.