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. Credit: Pathway Genomics

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."

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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.