Gene-Test Services Mislead Public, U.S. Government Report Says

Four gene-testing companies are misleading U.S. consumers by providing unclear or conflicting information on the risk of disease, according to a government investigator who sampled the services on the Internet.

Gregory Kutz led a probe for the Government Accountability Office by setting up customer accounts with Navigenics of Foster City, California, 23andMe Inc. of Mountain View, California, Pathway Genomics Corp. of San Diego and DeCode Genetics Inc. of Reykjavik, Iceland, and sending them DNA from five people. The companies’ reports assessing health risks were “medically unproven and so ambiguous as to be meaningless,” Kutz said in his report, presented today at a hearing in Washington.

The oversight subcommittee of the House Committee on Energy and Commerce is evaluating the public-health effects of direct- to-consumer genetic tests. The U.S. Food and Drug Administration has said it will step up regulation of gene-testing companies.

“The results show that the tests are not ready for prime time,” Kutz told the committee.

A representative for Navigenics told a female customer in a recorded telephone conversation played for the committee that the above-average risk prediction she was given for breast cancer “meant she was ‘in the high risk of pretty much getting’ the disease.” Experts consulted by the GAO called the statement “‘horrifying’ because it implies the test is diagnostic,” according to the report.

Photographer: Sandy Huffaker/Bloomberg

A technician tests DNA samples at Pathway Genomics Corp. The company is preparing to sell home gene-testing kits. Close

A technician tests DNA samples at Pathway Genomics Corp. The company is preparing to... Read More

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Photographer: Sandy Huffaker/Bloomberg

A technician tests DNA samples at Pathway Genomics Corp. The company is preparing to sell home gene-testing kits.

Surreptitious Swabbing

In another instance, a representative of Pathway Genomics told a customer that it would “absolutely” be acceptable to surreptitiously get some DNA from her fiancée and submit it for a test that would determine his ancestry. Such an action would be illegal in many states, Kutz testified.

Pathway considered this to be a serious incident, David Becker, the company’s chief scientific officer, told the committee. The customer service agent who made that comment was retrained, he said.

“We take responsibility for that particular action,” Becker said. “That is against our policy.”

Kutz said he submitted his own DNA to all four companies and was told by 23andMe and DeCode that his risk for developing prostate cancer was average, while Pathway told him it was below average and Navigenics said it was above average.

The dueling results provided by the companies may stem from the fact that each of them considers different numbers of genes that may suggest risk, Ashley Gould, chief legal counsel for 23andMe, told the committee.

Dueling Results Unacceptable

“We agree it’s not acceptable to get the different results,” Gould said. “We need standards” that would cover all purveyors of gene test results.

23andMe will submit its own plan for regulating the industry to the FDA tomorrow, Gould said.

Vance Vanier, chief executive officer of Navigenics, said the recorded comments made to consumers by company representatives were “extraordinarily disappointing.”

The FDA’s recent efforts to monitor gene-testing companies and require them to seek agency clearance for marketing their tests were spurred by the increasingly high profile the companies have taken in promoting the services, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told the committee.

‘Why Didn’t We Act?’

When Pathway Genomics announced in May its intention to sell its test kits in Walgreen Co.’s retail stores, that “lit a fire” under the FDA, he said.

“If there’s any issue with the FDA, it’s why didn’t we act sooner,” Shuren said.

While genetic knowledge is rapidly evolving, the ability to accurately predict disease risk from most gene tests is still in its infancy, said James Evans, a professor of genetics and medicine at the University of North Carolina at Chapel Hill.

“We have no idea and neither does anybody at those companies about how to interpret those risks,” he told the committee. “We are nowhere near that point now” where accurate risk assessment can be made for most diseases by scanning people’s genes.

Pathway’s Becker said his company was meeting with the FDA and supported development of “prudent” regulations covering the gene-testing industry.

Kari Stefansson, chief scientific officer of DeCode Genetics, said in a telephone interview that he wasn’t invited to testify before the committee.

“I feel extraordinarily confident that what we are reporting is correct,” he said. “I can only be held responsible for what we do,” not other companies.

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To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

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