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Consumer Genetic Tests Under Scrutiny

Questions arise over several companies’ plans for over-the-counter genetic tests.

On May 19, the U.S. House of Representatives Committee on Energy and Commerce sent a toughly worded letter to three CEOs, including James Plante of San Diego-based Pathway Genomics. Pathway was preparing to sell an over-the-counter genetic-testing kit at Walgreens. The product, called Genetic Health Report, purported to test for more than 70 health issues, including predispositions to Alzheimer’s, breast cancer, and diabetes. But the committee’s questions prompted Walgreens to postpone its plans to sell Genetic Health Report.

Testing the FDA: Pathway Genomics, a startup that sells a genetic testing kit to consumers over the Internet, garnered regulatory attention when it announced plans to sell the test at Walgreens.

The committee’s action could mark a crackdown on companies that sell genetic tests directly to consumers. The tests–which use saliva samples–have been sold, mostly over the Internet, with little interference from authorities, including the U.S. Food and Drug Administration. But some experts in law and genetics say Walgreens’s plan to stock the tests on shelves may have made enough of a splash to change all that. “We could see a demand for more transparency from these companies, so consumers can clearly see what they’re testing for, and what the evidence is” for the legitimacy of the results, says Daniel Vorhaus, attorney at Robinson, Bradshaw & Hinson in Charlotte, NC, and editor of the firm’s Genomics and Life Sciences blog.

The committee is demanding that consumer genetic-testing companies provide documents that describe the accuracy of the tests, and how the analysis of the results takes into account such factors as age, gender, and geographic location. Less than two weeks before the committee mailed its letters, the FDA sent a letter to Pathway requesting that Plante justify Genetic Health Report’s lack of FDA approval.

An FDA spokesman said in an e-mail that the other two companies that were contacted by the House committee–23andMe and Navigenics–had also been asked to defend their lack of FDA clearance: “This type of communication is often an initial step to open discussions with companies to clarify the FDA’s role in regulating their products and it’s also a step to gather more information about the products themselves.”

The three companies contacted by the House committee declined to comment for this story, though all released public statements expressing their willingness to cooperate with the investigations. “Pathway is in compliance with currently applicable regulations and guidelines for our laboratory and the services we offer to our customers,” said a company statement.

As it stands, the regulations governing genetic tests are a bit muddy. Pathway’s statement says the company has a certification known as Clinical Laboratory Improvement Amendments (CLIA), a federal certification that merely establishes quality standards for the laboratories that perform the tests.

But should the FDA be more vigilant? Most genetic tests–including those given by doctors–are subject to the FDA’s medical-device regulations. There are three classes of medical devices, each requiring an increasing degree of regulatory control. Depending on the nature of the test and what reagents are used to produce the results, the consumer genetic tests may or may not require premarket approval, though they must include a disclaimer stating that they have not been cleared by the FDA. The agency’s discussions with Pathway and its rivals may result in more such cautionary language being displayed prominently on packaging and consumer leaflets.

Some genetics experts believe consumers need even more comprehensive information about the limitations of genetic testing. They point out that scientists have not yet decoded the genetic causes of most diseases and many uncertainties surround genetic testing.Take BRCA1 and BRCA2, for example. While mutations in these genes have been linked to breast cancer, less than 10 percent of women who develop the disease actually test positive for the genes. For other diseases, such as Alzheimer’s, very few genes have been linked to the illnesses, and it’s unclear how important those genes are in the diseases. So genetic tests might create unwarranted fear in some patients, says Hope Northrup, director of the Division of Medical Genetics in the Department of Pediatrics at the University of Texas Medical School at Houston.

Edward McCabe, codirector of the Center for Society and Genetics at the University of California at Los Angeles, believes consumers who buy genetic tests–either online or on store shelves–should be instructed on exactly what each result can accurately predict and what it can’t. The FDA should have the authority to vet the tests, as well as the information that comes with them, he says. “Otherwise inappropriate health-care decisions could be made.”

The FDA and Congress are unlikely to outlaw the marketing of genetic tests to consumers altogether, most experts believe. But Vorhaus predicts they will put pressure on the U.S. Federal Trade Commission to monitor the messages that these companies are giving to consumers.

In any case, the fact that these agencies are paying attention to genetic testing could be enough to change how Pathway, Walgreens, and other companies communicate the value of their products to consumers. “Shine a bright light on the industry,” Vorhaus says, “and you’ll get the industry to monitor itself.”

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