Pathway Genomics Corp., 23andMe Inc. and Navigenics Inc. are being asked by U.S. lawmakers for information on the reliability of the genetic tests they market to consumers.
Representative Henry Waxman, a California Democrat who heads the House Energy and Commerce Committee, and three other lawmakers sent letters to the companies today requesting details on the products, citing “concern from the scientific community regarding the accuracy of test results.”
Pathway, Navigenics and 23andMe, all closely held, market home test kits online that allow consumers to collect saliva samples and send them to the companies for DNA analysis. Pathway, based in San Diego, also planned to sell its tests starting May 14 at Walgreen Co., the largest U.S. drugstore chain. The Deerfield, Illinois-based retailer halted plans to carry the kits after the Food and Drug Administration told Pathway in a May 12 letter that the product appears to be a medical device subject to agency review.
“Recent press reports suggest that at least one genetic testing company is now seeking to sell these tests in retail locations, despite concern from the scientific community regarding the accuracy of test results,” Waxman said in the letter.
June 4 Deadline
The lawmakers gave the companies until June 4 to submit documents on the ability of the tests to identify consumers’ risks for illnesses. The legislators also requested information on the proficiency of the companies’ lab testing, policies on consumer privacy and whether the kits comply with FDA rules.
The letters were sent to Pathway Chief Executive Officer James Plante; Vance Vanier, chief executive officer of Foster City, California-based Navigenics Inc.; and Anne Wojcicki, president of 23andMe in Mountain View, California.
The FDA should keep a “close eye” on commercial gene tests because there aren’t any standards to ensure the kits are reliable in gauging a person’s risk for illnesses such as heart disease or diabetes, said Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics in Philadelphia.
“A lot of companies have tried to push this forward as just informational, but that’s just nonsense,” Caplan said today in a telephone interview. The tests may have health consequences if, for example, people “go off and drink milkshakes all day” after a DNA analysis indicates they have a low risk for heart disease, he said.
Navigenics has talked with “key stakeholders” in Washington this week, including senior aides to Waxman’s committee, said Amy DuRoss, the company’s vice president of policy and business affairs.
“We will be glad to respond to the committee’s requests in a timely fashion, and we look forward to further cooperation with committee members in the future,” DuRoss said today in an e-mail.
“We look forward to sharing information detailing what individuals can learn about their own bodies through personal genetic testing and how our company is facilitating important scientific research in the field,” 23andMe said today in a statement e-mailed by Adam Isserlis, a spokesman for the company with Rubenstein Communications in New York.
Robert Blodgett, a Pathway spokesman, didn’t have an immediate comment on the lawmakers’ letter.