MOUNTAIN VIEW -- In a harsh warning letter made public Monday, the U.S. Food and Drug Administration ordered Google (GOOG)-backed 23andme to stop selling its widely used genetic test to consumers because the company has failed for four years to prove the product is medically useful, and the agency fears it could endanger lives.
In a statement, the company acknowledged that "we have not met the FDA's expectations" for the test, which costs $99, and it said that it was committed to working with the FDA to address its concerns. But the action is a significant setback for the company, whose CEO, Anne Wojcicki, is married to but separated from Google co-founder Sergey Brin and which in December said it received more than $50 million from Brin, Google Ventures and other sources.
The warning letter comes as regulators have struggled for years with how to regulate the burgeoning field of personalized medical testing, which has prompted government investigations and aroused deep concerns from some health experts.
The letter notes that the FDA has worked with 23andMe since 2009 to help it comply with governmental requirements regarding the safety and effectiveness of its "Personal Genome Service," which tests people's saliva for genetic indications of 254 disease conditions and other potential health risks.
The agency said it has had "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges and dozens of written communications" with the company. However, it added, "We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses."
Some uses for the test "are particularly concerning," the FDA said, "because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications." A false-positive for breast or ovarian cancer, for example, "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist," the FDA said.
Noting that 23andme recently announced it was launching television commercials for its test, the FDA demanded the company "immediately discontinue marketing" until the test is federally approved and gave 23andme 15 working days to explain what it is doing to address the agency's concerns. Otherwise, the FDA said it might consider "civil money penalties" or other actions against the firm.
Officials at 23andme, which is a private company, declined comment on what impact the FDA's action might have on their business and whether they will continue processing genetic tests. With Google's backing, 23andme has obtained $126 million since its inception and has about 400,000 customers, according to an article this month in Fast Company magazine.
It's likely that 23andme will try to resolve the dispute through further negotiations with the FDA, said Colleen Heisey, a lawyer specializing in FDA regulations. But if it fails to satisfy the agency, she added, the FDA might seek an injunction to halt 23andme's business.
"This is serious," Heisey said of the warning letter. "It's intended by the FDA to be a wake-up call."
Marcy Darnovsky, executive director of the Berkeley-based Center for Genetics and Society, said the FDA may have let 23andme stay in business as long as it has because genetic tests sold directly to consumers are relatively new, and the agency wants to be careful how it regulates them. But she said it's crucial such companies are closely monitored.
"If they are giving health information, there has to be some oversight," she said. "Otherwise, we're back to the snake-oil era."
DNA tests sold directly to consumers have been criticized as having limited value because they typically examine only a small sample of a person's genetic makeup.
In 2010, investigators from the U.S. Government Accountability Office concluded that 23andMe and Navigenics of Foster City were offering information that was "misleading and of little or no practical use." Although both companies defended their products, the agency blasted them for drawing unsupportable conclusions and making health predictions that didn't always jibe with their customers' actual medical conditions.
Navigenics has since been bought by Life Technologies of Carlsbad, which only does genetic tests for research service and has no problem with the FDA, according to Life Technologies spokeswoman Suzanne Hatcher.
DNA tests such as those offered by 23andme also have aroused the concern of California health authorities. In 2008, they launched an investigation into the marketing of such tests, saying some companies lacked proper state licenses.
That same year, a study in the American Journal of Human Genetics concluded that "there is insufficient scientific evidence" to prove the tests "are useful in measuring genetic risk for common diseases." Also in 2008, a U.S. Department of Health and Human Services advisory committee found "significant gaps in the U.S. system of oversight of genetic testing that can lead to harms."
Contact Steve Johnson at 408-920-5043. Follow him at Twitter.com/steveatmercnews.