By Toni Clarke
(Reuters) - The U.S. Food and Drug Administration has warned 23andMe, a company backed by Google Inc, to halt sales of its genetic tests because they have not received regulatory clearance.
23andMe, which was founded in 2006 by Anne Wojcicki with the backing of Google, sells a $99 DNA test that the company says can detect a range of genetic mutations and provide information about a person's health risks. Wojcicki recently separated from her husband, Sergey Brin, a co-founder of Google.
In a warning letter dated November 22 and released on Monday, the FDA said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, "as FDA has explained to you on numerous occasions."
The privately held company, which is based in Mountain View, California, acknowledged receipt of the letter and said in a statement that "we recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission."
The FDA said some of the intended uses of the company's Saliva Collection Kit and Personal Genome Service (PGS) are particularly concerning, including risk assessments for certain cancers.
The agency said that if the company's risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.
The FDA has not cleared any genetic tests that are offered directly to consumers.
The FDA said in its letter that the company submitted applications in July and September of 2012 for several disease areas.
"However," the FDA said, "to date your company has failed to address the issues described during previous interactions with the Agency" or provided additional information requested. As a result, the FDA said the applications "are considered withdrawn."
The agency said it had been "diligently working" to help the company comply with the law, and has spent significant time evaluating the intended uses of the product. It said it provided detailed feedback to company through more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications.
"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.
While 23andMe may not have been communicating with the FDA, Wojcicki has been talking at length to the media. Earlier this month she told the New York Times that the company had mapped the genotype of 475,000 people over the last five years and expected to "hit a million" sometime in the first quarter of next year.
In a recent article in Fast Company, Wojcicki said her ultimate goal was to sign up 25 million people. "Once you get 25 million people, there's just a huge power of what types of discoveries you can make," she said.
The company's name refers to the 23 pairs of chromosomes that make up each individual's genome.
After years of trying to obtain from 23andMe the information it needs to ensure the tests are accurate, the FDA appears to have finally lost patience. The company will not be able to sell its tests for medical purposes until it submits the necessary data.
The company said it its statement that "our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
(Additional reporting by Sharon Begley in New York; editing by Matthew Lewis)