The U.S. Food and Drug Administration is telling California-based company 23andMe to stop selling a DNA testing kit used to inform people of their ancestry, paternity, diseases, reactions to drugs and possible genetic vulnerabilities.
The $99 test kits have been flying off the virtual shelf since being reduced in price from $299 in December 2012.
Kendra Cassillo, a spokeswoman for the company, says 23andMe has clocked 500,000 customers.
On Friday, the FDA ordered the company to stop selling the tests, which require users to mail the company a saliva sample for analysis.
In a letter dated Nov. 22 the FDA says "23andMe must immediately discontinue marketing the [test] until such time as it receives FDA marketing authorization." The FDA gave the company 15 business days to address a litany of issues or face property seizure and/or civil penalties.
As of Monday, the company appeared to be still marketing the product online. Website visitors are directed to an order form that appears to be functional. It's unclear whether the company is taking legal action to contest the FDA's order. Cassillo declined to offer further comment.
Issues cited in the FDA letter include "study protocols and clinical and analytical validation requirements... potential classifications and regulatory pathways... [and] potential risk mitigation strategies."
The letter, signed by Office of In vitro Diagnostics and Radiological Health Director Alberto Gutierrez, says the FDA is "concerned about the public health consequences of inaccurate results" and says "the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
The FDA says it attempted to resolve its concerns during "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications," but says it did not receive any communication from the company since May.
"[W]e have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the [test's] uses and consumer base without obtaining marketing authorization from FDA," the letter says, referencing a TV ad campaign that launched in August.
"[M]ore than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the [test]," the letter says.
The company attracted many headlines since its 2006 launch. Among them, a May Slate article that offered a cautionary tale about paternity – noting one user found her biological father was different from the one she believed she shared with her siblings. The firm provided testing for Harvard University Professor Henry Louis Gates' 2012 PBS series "Finding Your Roots."
23andMe co-founder Anne Wojcicki is married to Google co-founder Sergey Brin. The couple is currently separated. Google invested at least $3.9 million in the company.
A statement released to the media doesn't address the specific steps 23andMe will take as it addresses the FDA's concerns.
"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," the company statement says. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."