Genetic Test Service 23andMe Ordered to Halt Marketing by FDA Regulators Cite Risk of False Results, Unnecessary Health Procedures By PETER LOFTUS Updated Nov. 25, 2013 9:40 p.m. ET U.S. regulators ordered genetic-testing company 23andMe Inc. to stop marketing its $99 mail-order kit, citing the risk that false results could cause consumers to undergo unnecessary health procedures such as breast-cancer surgery. The warning to the Google Inc. GOOG +1.19% -backed company from the Food and Drug Administration follows a debate that has grown as hundreds of thousands of people have turned to direct-to-consumer genetic tests for clues about disease risk and ancestry. Proponents say people have a right to direct access to their genetic data. But some public-health experts worry about inaccurate results or the misuse of data outside of the guidance of doctors and genetic counselors. The U.S. Food and Drug Administration ordered 23andMe to stop marketing its $99 mail-order genetic test. WSJ's Ron Winslow has details on digits. Are genetic-testing services such as those provided by 23andMe prompting people to get unnecessary procedures based on dubious test results? Georgetown University bioethics professor Dr. James Giordano discusses on the News Hub.
Letter: FDA Orders 23andMe to Halt Sales In a letter to 23andMe Chief Executive Anne Wojcicki, the FDA said that the company doesn't have proper clearance to market the DNA testing kit, and that 23andMe hasn't sufficiently worked with the agency to secure such approval. The FDA said it hasn't heard from the company since May, and has learned that 23andMe started new marketing campaigns for the test, including television commercials. Privately held 23andMe is one of the leaders of the consumer genetic-testing market. In promotional materials, the company says its saliva-based test identifies more than 240 genetic traits that could offer clues to an individual's health or risk of disease. The company counts the venture arms of Google and Johnson & Johnson JNJ -0.60% among its investors. Google referred questions to 23andMe, and J&J declined to comment. Ms. Wojcicki, who co-founded the firm in 2006, is married to Google co-founder Sergey Brin ; the couple no longer live together, AllThingsD reported in August. The FDA said it could take more serious regulatory action, including product seizures, if 23andMe doesn't take adequate corrective steps in response to the FDA letter. 23andMe, based in Mountain View, Calif., issued a written statement Monday saying "we have not met the FDA's expectations regarding timeline and communication" for the company's regulatory submission seeking marketing authorization for its service. The company said it would work with the FDA to address its concerns. An outside company spokeswoman declined to comment further and said Ms. Wojcicki wasn't available for interviews. 23andMe has previously said it has strengthened its quality-control systems to ensure accuracy of test results, and it educates its customers about the significance of the test results, encouraging them to discuss the results with doctors and genetic counselors. The majority of genomic testing is still carried out in academic research labs, but tests aimed at consumers have multiplied in recent years. Some geneticists and consumer advocates say the consumer-targeted tests have played a positive role in helping raise public awareness about genetics. A group of customers rallied to the support of 23andMe on the company's Facebook page on Monday; an online petition was started on WhiteHouse.gov, asking the Obama administration to overrule the FDA's action. But others said they would welcome more regulatory oversight. David Goldstein, a professor of genetics at Duke University, said the tests weigh in on serious topics like whether a person carries genetic mutations that could cause disease in offspring. That sort of information can affect a person's decision about whom to marry or whether to have children, and can be dangerous if inaccurate, Dr. Goldstein said. "It's more actionable information now. And we're all getting nervous. In that context I welcome what the FDA has done," he said. David Valle, director of the McKusick-Nathans Institute of Genetic Medicine at Johns HopkinsUniversity, said any companies wishing to sell genetic tests "should be willing to undergo scrutiny of their laboratory processes." He added that no consumer should be left on his or her own to interpret such "complicated and highly nuanced" data, and said a health-care professional should ideally be involved. Consumers can order 23andMe's personal genome service online; once they receive a "spit kit," they provide a saliva sample and ship it back to 23andMe. The company says it uses technology provided by gene-sequencing company Illumina Inc. ILMN -0.06% to analyze the genetic information that might make people predisposed to diseases including diabetes and breast cancer. The name 23andMe is a reference to human DNA being organized into 23 pairs of chromosomes. The company says it has more than 475,000 genotyped customers. 23andMe started its first national TV advertising campaign in the summer, including one spot featuring people next to graphical representations of their genetic profiles, saying "This part makes my eyes blue," and "I might have an increased risk of heart disease." The FDA said in its warning letter it is concerned about some of the intended uses for the 23andMe test, including detecting mutations in so-called BRCA genes that can signal increased risk for breast cancer. The FDA is concerned that the 23andMe test could produce a false positive for such mutations, which "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening," while a false negative could miss an actual risk for the disease. The FDA also cited concerns about false results from the 23andMe test's screens aimed at predicting patient response to certain drugs such as the blood thinner warfarin. Patients could have serious blood clots or bleeding if they took an incorrect dose of warfarin based on the 23andMe test results, the FDA said. An FDA spokeswoman said the agency "needs to review genetic tests sold directly to consumers to make sure they are safe and do what they claim to do." She said the agency issued its warning letter "after the company has repeatedly failed to address specific concerns outlined by the agency since July 2009." 23andMe failed to submit information requested by the FDA, "putting consumers at risk of receiving inaccurate information that could result in delayed or inappropriate medical care," said the FDA spokeswoman. The FDA has previously expressed concerns about the emerging field of direct-to-consumer genetic tests. In 2010, agency officials said they considered the tests "high risk," and told 23andMe and other companies that it considered their tests to be medical devices requiring FDA approval. 23andMe has defended its test, saying people have a right to their personal genetic data. The company says the genetic data complements family history in helping people to make informed decisions with their health-care providers. The company applied for FDA clearance to market its test kit for several purposes in 2012. In January 2013, the company told the FDA it was conducting additional work on its application, including studies that would take several months to complete. But the FDA said in its letter that 23andMe hadn't started certain studies that would be necessary to support a marketing submission. The FDA said it now considers 23andMe's marketing application to be withdrawn. The company has 15 working days to respond to the FDA letter outlining specific actions it has taken to address FDA concerns. Colleen Heisey, a Jones Day attorney focusing on food and drug law, said it appeared the FDA used its regulatory discretion to allow 23andMe to continue selling the product the past several years while the agency worked with the company on marketing authorization. The new FDA warning letter "shows there's an end to that patience," said Ms. Heisey. —Jeanne Whalen and Rolfe Winkler contributed to this article.
The FDA Just Ruined Your Plans To Buy 23andMe's DNA Test As A Christmas Present Kashmir Hill Forbes StaffReally? In six months, a company choosing to work in a business in which it knows the FDA believes it has jurisdiction decided not to respond to the agency for six months? At a time when 23andMe was going to be launching an advertising campaign to try to sign up a million people to its service? At a moment when Anne Wojcicki, the company's chief executive, was going to be on the cover of FastCompany talking about how 23andMe is revolutionizing health care? And 23andMe thought the FDA was just going to, I don't know, not notice? Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration.The FDA's account seems to show the agency giving 23andMe a lot of chances, and to show a willingness to find a way to work with the startup. The FDA references 14 face-to-face meetings and telephone calls, hundreds of emails and dozens of written communications during which the agency said it provided specific feedback on study protocols that would prove 23andMe's tests were useful as diagnostics and other tests to prove the 23andMe kits gave consistent results. Instead, 23andMe expanded how its test was used. In January, the FDA says the company promised that it was doing extensive studies that would take months to complete – and then that promised data never materialized. This is not the way to deal with a powerful government regulator.23andMe's statement on the news? "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."It's worth remembering the history of how 23andMe launched five years ago. Initially it was one of three companies hoping to bring three different personal genomics services to consumers. For various reasons, the others, DeCodeMe and Navigenics, did not survive. But 23andMe managed to squeak by based on the strength of its backers and also through a stalemate with regulators: the company presented its test not so much as a medical device but as a fun way to learn about genetics. It wasn't a way to find out medically actionable disease risk, it was a way to find out if you had a gene that made your pee smell when you ate asparagus.But that wasn't Wojcicki's vision for the company, nor was it the vision of her husband, Google billionaire Sergey Brin. (They are now separated.) Wojcicki has been pretty public that the idea behind 23andMe was that it was going to give people information about their health, and also allow scientific research about genetics to proceed in a brand new way.23andMe's business was never going to be selling genetic test kits at $100 a pop; even if the company reaches its goal of selling 1 million kits cumulatively, that's only $100 million in revenue, a small sum by the standards of biotech and play money at Google. But what a large enough database of people who were sharing not only genetic information but information about their health and their bodies offered was something greater: a tool that could be used to find new genetic connections, for detecting drug side effects, maybe even for finding new diagnostics or cures. That's why 23andMe needs to get to 1 million kits sold – to build that database. That promise has brought on other investors, including Facebook billionaire Yuri Milner.If the selling point of the 23andMe kit were that it allowed people to participate in science, maybe the FDA could have let this go. But 23andMe's website specifically told the story of people who got tests results related to breast cancer genes. The FDA probably felt it had little choice. This is not the story of a big regulator choosing to squash a small company, but of a company that decided that it didn't have to follow the rules.I hope that this doesn't backfire on 23andMe, because on many very big issues, the company is very right. The FDA would probably like to be able to regulate genetic tests much the same way as it does drugs, regulating each individual use to make sure there is enough data to support it. But that's untenable; there are about two dozen drugs approved each year, while there are tens of thousands of genes that mean different things in different combinations, or when there are different changes in them. The FDA did just approve DNA sequencers made by Illumina, which also makes the chips used by 23andMe to look at scattered spelling changes in the genome, as a tool for use by laboratories, so maybe it's getting the picture. We need something like 23andMe to help develop systems for letting people know how to deal with this genetic information, and for creating a world where people can actually start to deal with lots of health data. But outside of a crowd of libertarians and genoscenti, the company does not have the political support it needs for a fight against the FDA. And none of its high-minded ideals release it from the requirement the FDA wants to enforce: that a medical device has to work. I hope 23andMe and FDA can find a way to thread this needle, but this isn't a promising start.
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