FDA warns Google-backed 23andMe to halt sales of genetic tests

Mon Nov 25, 2013 5:11pm EST

Panelists Anne Wojcicki, co-founder of 23and Me Inc. and 2006 Nobel Peace Prize Laureate Muhammad Yunus (R), managing director, Grameen Bank from Bangladesh take part in the Revolutionizing Health Care and Research in the Developing World panel at the Global Overview panel at 2008 Milken Institute Global Conference in Beverly Hills California April 28, 2008. REUTERS/Fred Prouser

Panelists Anne Wojcicki, co-founder of 23and Me Inc. and 2006 Nobel Peace Prize Laureate Muhammad Yunus (R), managing director, Grameen Bank from Bangladesh take part in the Revolutionizing Health Care and Research in the Developing World panel at the Global Overview panel at 2008 Milken Institute Global Conference in Beverly Hills California April 28, 2008.

Credit: Reuters/Fred Prouser

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(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, sells a $99 DNA test that the company says can detect a range of genetic variants 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 false positive tests for certain breast or ovarian cancers could lead a patient to undergo preventative surgery including mastectomy, intensive screening or other potentially risky procedures. A false negative could result in a failure to recognize and act on an actual risk.

23andMe will not be able to sell its tests for medical purposes until it submits the necessary data.

The FDA has not cleared any genetic tests that are offered directly to consumers.

Kathy Hudson, deputy director for science, outreach, and policy at the National Institutes of Health, said the FDA action clarifies its expectations for direct-to-consumer genetic testing. "NIH believes genetic information has a great potential to 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 a particular disease, might apply to some ethnic groups but not to others. As a result, a consumer might think she has an elevated risk of some illness when in fact she does not.

On its website "the company quotes numbers for risk from published scientific papers, but you'd have to be pretty sophisticated to know that if the study was done on western Europeans it might not be relevant to you if you're Chinese," said geneticist Dr Jeff Murray of the University of Iowa and president of the American Society of Human Genetics (ASHG).

The FDA said in its letter that 23andMe had submitted applications in July and September of 2012 for several uses of its saliva test but had failed to address issues raised by the agency or to provide additional information requested. As a result, the FDA said, the applications "are considered withdrawn."

The company said its relationship with the FDA is "extremely important to us and we are committed to fully engaging with them to address their concerns."


Dr. David Agus, a professor of medicine and engineering at the University of Southern California and founder of Navigenics, one of the first personal-DNA testing companies, said the FDA's letter to "is not a death knell to personal DNA testing" but should be a wake-up call. "We have to be transparent with consumers about what sequencing their genome can and cannot reveal," he added.

Navigenics was acquired last year by Life Technologies Corp.

The FDA said it had been "diligently working" to help 23andMe comply with the law, and spent significant time evaluating the intended uses of the DNA-testing product. It said it provided detailed feedback to the 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 her company had mapped the genotypes of 475,000 people over the last five years and expected to "hit a million" in the first quarter of 2014.

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 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.

"I think this will certainly grab the attention of a lot of other companies out there," said Joseph McInerney, executive vice president of the ASHG.

(Reporting by Toni Clarke in Boston and Sharon Begley in New York; Editing by Matthew Lewis and Tim Dobbyn)

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Comments (18)
Eideard wrote:
Yup. Someone who gets a potential false positive runs the risk of undergoing unnecessary surgery. As long as the surgeon fails to run additional more detailed tests to confirm or contradict the results of the original test. How likely is that?

Of course you may go and perform the surgery yourself with a rusty can opener. But, then, you’d be guilty of practicing medicine without a license.

Seems to me a letter of caution on file would have been sufficient – urging further examination. But, then, that may already be the case, eh. Don’t our FDA bureaucrats already have a list of truly useful functions they may be performing instead of this waste of taxpayer’s money.

Nov 25, 2013 11:32am EST  --  Report as abuse
isolate wrote:
“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 [sic] surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.”

As hard as I try, I can’t imagine someone immediately signing up for surgery after reading their 23andMe report. For one thing, the entire medical establishment would stand in their way. I’m a cancer survivor and I’ve had the 23andMe testing done, so I have a bit of perspective on both. The 23andMe screening produces results that are like an insurance company’s actuarial tables: they’re not designed to assess an individual, only the far larger group they may belong to.

Screening, however, is always a good idea, whatever the motivation. Had I acted a year before I did, I might have been spared major surgery and chemo.

Nov 25, 2013 12:04pm EST  --  Report as abuse
Boilers wrote:
25 million data points. the “power” or the probability of correctly identifying risks of cancer will be high if they ever reach that goal. unfortunately, not everyone understands the legitimacy this brings to our fingertips.

remember the structure behind these programs includes many many years of experience from doctors and scientist.

if they ever get all this data, i would trust 23Me, the power in their 23million data points and many years of science and medical research as the structure of these algorithms.

or you can go with your small sample size, n=2 doctors to dictate the next step of your diagnosis.

Nov 25, 2013 3:28pm EST  --  Report as abuse
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