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Consumer Gene Tests Should Be Regulated in U.S.

Gene testing companies such as 23andMe Inc. and DeCode Genetics Inc. should be regulated because consumers may make wrong medical decisions based on inaccurate or misinterpreted results, scientists said.

The tests are promoted as providing information about a person’s likelihood to develop a wide range of traits and conditions, from excessive ear wax to cancer and Alzheimer’s disease. More than 90 percent of results aren’t seen by an outside reviewer before being sent to the consumers, according to a commentary in the journal Science.

The U.S. Food and Drug Administration is reviewing the tests, and the Government Accountability Office said in July that the companies were misleading consumers by providing unclear or conflicting information. Misinterpretation of the data may cause harm to consumers who take action on their own, said the scientists who wrote the commentary. In one study, 40 percent of Alzheimer’s patients reported increasing their medications after getting the tests, the authors said.

“The first step is transparency, for consumers to have access to accurate information,” said Amy McGuire, an associate professor of medicine and ethics at Baylor College of Medicine in Houston who was an author of the commentary, in a telephone interview.

One difficulty in regulating these tests, also made by Pathway Genomics Corp. and Navigenics Inc., is that they combine genetic traits that don’t have a health-care impact, such as a proclivity to be a fast runner, with more serious medical information, such as prostate cancer risk, McGuire said.

Breast Cancer Risk

The authors said that some information, such as ancestry, may not have medical consequences and should only be checked to make sure that it’s accurate. Other assays, such as those that measure breast cancer risk, should only be performed with counseling from a health-care professional, the authors wrote.

“Clearly with medical information with important health implications, patients need to be able to attain that information in an environment where their options are laid out,” McGuire said. “And someone can help understand not just what does that result tell you, but what does it mean in the context of other risk factors.”

Pathway Genomics announced in May that it intended to sell its kits in Walgreen Co.’s retail stores, which sparked an effort by the FDA to monitor the testing companies. Walgreen shelved the plan after the FDA opened a review, saying the gene tests were medical devices. The tests work by collecting a person’s saliva and analyzing DNA from the spit sample in a lab.

FDA Review

“This paper presents some interesting options for the oversight of DTC testing,” said Erica Jefferson, a spokeswoman for the FDA, in an e-mailed statement. The paper’s approach may not be the best option, and the FDA is developing a way to monitor these tests, with the goal that direct-to-consumer tests be safe and effective when used without guidance from a health-care professional, she said.

Brenna Sweeny, a spokeswoman for Foster City, California-based Navigenics, and San Diego-based Pathway Genomics didn’t immediately return a call requesting comments.

Edward Farmer of DeCode referred comment to previous statements by Kari Stefansson, executive chairman and president of research for DeCode. Stefansson said in June that DeCode welcomes regulation by the FDA.

‘Entirely Confident’

“While 23andMe is entirely confident in its own reports developed in conjunction with physician and scientific advisers, the company is in discussions with the FDA regarding an improved regulatory framework for genetic testing,” said Ashley Gould, general counsel for the Mountain View, California-based company, in an e-mailed statement. “23andMe believes new regulations should provide transparency across the industry so that consumers know what they are getting from the services they choose.”

The FDA should review all tests before they come to market, today’s editorial said. Less risky ones, such as those that trace ancestry or susceptibility to extra earwax, could be subject to a light review and a national registry to disclose uncertainty.

Groups such as GeneTests, a website that displays genetic information, and the National Institutes of Health should play a role in making sure information from testing companies about methods and accuracy is publicly disclosed, said McGuire and her colleagues in the editorial.

Professional Review

More risky tests, such as those for Huntington’s disease or cancer, should be reviewed by a health-care professional, the scientists said. Involving a doctor or nurse would limit access to tests because it would make them more expensive. There would still be a chance that patients would be unnecessarily treated if the reviewers weren’t properly trained, the authors said.

Ira Loss, an analyst with Washington Analysis, said consumers don’t know how accurate test results are without any independent assessment.

“I’m not surprised an editorial like this is being published,” Loss said in a telephone interview today. “There’s a very strong sense in the medical community that the more serious genetic information shouldn’t arrive in an envelope, particularly if there’s a bad message to be delivered.”

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