ABC7 News profiled 23andMe previously, when the number of people who'd purchased the direct-to-consumer DNA test kits had grown to a 500,000 users after the company lowered the price to $99.
23andMe has serious financial backing from Google, as the CEO is Google founder Sergey Brin's wife. It has expanded its offerings dramatically over the six years since it launched but now, the FDA is ordering it to slow down and catch up with some regulatory requirements.
23andMe's website promises health reports based on users' DNA on more than 240 health conditions and traits, direct to you, for $99. On Monday, the FDA made public a letter it sent to 23andMe last Friday ordering it to immediately stop marketing the Personal Genome Service, or PGS, because it does not have FDA clearance or approval.
The question is whether PGS is a consumer product or a medical device.
"The FDA has said this kit is a medical device which means that it needs to be approved and it needs to go through all these regulatory processes and studies, and that can take years," says Christina Farr who covers health for the VentureBeat website.
The genome service claims it can assess risk for serious diseases like breast cancer and Alzheimer's. The FDA worries that false-positives are as dangerous as false-negatives, saying in the letter that the "FDA is concerned about the public health consequences of inaccurate results" and that "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
The FDA thinks the genome service falls under the medical device category because consumers could act on the results as a diagnosis -- not just a prediction of risk.
"Patients don't really know how to interpret the results of these tests and they don't understand that it signifies risk and it doesn't necessarily mean that you are going to get breast cancer or Alzehimer's or any other kind of incurable condition," Farr explained.
23andMe issued a statement saying in part, "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The company has 15 days to satisfy the FDA's demands. One possible scenario is that it doesn't, it could end up hashing it all out in the courtroom.