* FDA: tests have not received marketing clearance
* 23andMe says it wants to address FDA's concerns
* FDA: action follows lengthy attempt to work with company (Updates with comment from NIH, American Society of HumanGenetics)
By Toni Clarke and Sharon Begley
Nov 25 (Reuters) - The U.S. Food and Drug Administration haswarned 23andMe, a company backed by Google Inc, to haltsales of its genetic tests because they have not receivedregulatory clearance.
23andMe, which was founded in 2006 by Anne Wojcicki, sells a$99 DNA test that the company says can detect a range of geneticvariants and provide information about a person's health risks.Wojcicki recently separated from her husband, Sergey Brin, aco-founder of Google.
In a warning letter dated Nov. 22 and released on Monday,the FDA said products that are designed to diagnose, mitigate orprevent disease are medical devices that require regulatoryclearance or approval, "as FDA has explained to you on numerousoccasions."
The privately held company, which is based in Mountain View,California, acknowledged receipt of the letter and said in astatement that "we recognize that we have not met the FDA'sexpectations regarding timeline and communication regarding oursubmission."
The FDA said some of the intended uses of the company'sSaliva Collection Kit and Personal Genome Service (PGS) areparticularly concerning, including risk assessments for certaincancers.
The agency said false positive tests for certain breast orovarian cancers could lead a patient to undergo preventativesurgery including mastectomy, intensive screening or otherpotentially risky procedures. A false negative could result in afailure to recognize and act on an actual risk.
23andMe will not be able to sell its tests for medicalpurposes until it submits the necessary data.
The FDA has not cleared any genetic tests that are offereddirectly to consumers.
Kathy Hudson, deputy director for science, outreach, andpolicy at the National Institutes of Health, said the FDA actionclarifies its expectations for direct-to-consumer genetictesting. "NIH believes genetic information has a great potentialto improve human health, but there need to be reliable,validated tests," she said.
One concern is that the results of genetics research,especially that linking a DNA variant to the risk of aparticular disease, might apply to some ethnic groups but not toothers. As a result, a consumer might think she has an elevatedrisk of some illness when in fact she does not.
On its website "the company quotes numbers for risk frompublished scientific papers, but you'd have to be prettysophisticated to know that if the study was done on westernEuropeans it might not be relevant to you if you're Chinese,"said geneticist Dr Jeff Murray of the University of Iowa andpresident of the American Society of Human Genetics (ASHG).
The FDA said in its letter that 23andMe had submittedapplications in July and September of 2012 for several uses ofits saliva test but had failed to address issues raised by theagency or to provide additional information requested. As aresult, the FDA said, the applications "are consideredwithdrawn."
The company said its relationship with the FDA is "extremelyimportant to us and we are committed to fully engaging with themto address their concerns."
Dr. David Agus, a professor of medicine and engineering atthe University of Southern California and founder of Navigenics,one of the first personal-DNA testing companies, said the FDA'sletter to "is not a death knell to personal DNA testing" butshould be a wake-up call. "We have to be transparent withconsumers about what sequencing their genome can and cannotreveal," he added.
Navigenics was acquired last year by Life TechnologiesCorp.
The FDA said it had been "diligently working" to help23andMe comply with the law, and spent significant timeevaluating the intended uses of the DNA-testing product. It saidit provided detailed feedback to the company through more than14 face-to-face and teleconference meetings, hundreds of emailexchanges, and dozens of written communications.
"However, even after these many interactions with 23andMe,we still do not have any assurance that the firm hasanalytically or clinically validated the PGS for its intendeduses," the FDA said.
While 23andMe may not have been communicating with the FDA,Wojcicki has been talking at length to the media. Earlier thismonth she told the New York Times that her company had mappedthe genotypes of 475,000 people over the last five years andexpected to "hit a million" in the first quarter of 2014.
In a recent article in Fast Company, Wojcicki said herultimate goal was to sign up 25 million people. "Once you get 25million people, there's just a huge power of what types ofdiscoveries you can make," she said.
The company name refers to the 23 pairs of chromosomes thatmake up each individual's genome.
After years of trying to obtain from 23andMe the informationit needs to ensure the tests are accurate, the FDA appears tohave finally lost patience.
"I think this will certainly grab the attention of a lot ofother companies out there," said Joseph McInerney, executivevice president of the ASHG.
(Reporting by Toni Clarke in Boston and Sharon Begley in NewYork; Editing by Matthew Lewis and Tim Dobbyn)
- Health Care Industry
- Anne Wojcicki