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Genetic lab 23andMe forced to halt marketing by FDA

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Genetic lab 23andMe forced to halt marketing by FDA Empty Genetic lab 23andMe forced to halt marketing by FDA

Post  LuvDinar Tue Nov 26, 2013 11:53 am

Genetic Test Service 23andMe Ordered to Halt Marketing by FDA
Regulators Cite Risk of False Results, Unnecessary Health Procedures

By PETER LOFTUS CONNECT
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 +0.95% -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. Photo: 23andMe.


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.

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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 0.00% 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 Hopkins University, 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 -1.13% 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.

Write to Peter Loftus at peter.loftus@wsj.com

LuvDinar

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