The Food and Drug Adminstration ordered online DNA testing company 23andMe to stop selling its DNA testing kit because it is apparently illegal and there’s no proof it works.
Founded by biotech analyst Anne Wojcicki, the wife of Google founder Sergey Brin, 23andMe sends out and collect saliva samples for DNA tests that cost $99. They test these samples and provide users with “240+ health conditions and traits” based on their genome.
“Based on your DNA, we’ll provide specific health recommendations for you,” says 23andme.com. "Get personalized recommendations."
The FDA says the company doesn’t make clear that there is a risk of false positives that could have potentially lethal consequences. The FDA says the company "must immediately discontinue marketing" and has given 15 days for 23andMe to inform the FDA how it plans to address the issues.
“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act),” said a warning letter to the company.
The concern is that a false positive will lead individuals to seek treatment for illnesses they don’t have and false negatives will keep others from seeking a health screening.
“For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive,” the FDA wrote, “it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
Genome testing is already a tricky business. Certain states won’t allow 23andMe samples to be mailed there because it is illegal to provide genetic testing without a licensed physician helping the consumer to interpret the results.
Despite the new ad campaign, 23andMe has been around for a while and the FDA says it has tried to help 23andMe comply with the FD&C Act for years.
“Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device,” wrote the FDA.
“Failure to take adequate corrective action may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties,” the letter concludes.
In October, 23andMe was issued a patent to create a "calculator" that would allowing prospective parents to pick and choose genetic traits for their baby.