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July 27, 2006 - A Senate committee chairman denounced at-home genetic tests sold over the Internet as "snake oil" after a government report released today branded the tests unreliable and misleading.
The tests are designed to alert consumers if they carry genetic mutations putting them at higher risk for diseases like diabetesdiabetes and hypertensionhypertension.
But today's report from the Government Accountability Office (GAO), the investigative arm of Congress, concluded they give consumers misdirected advice about disease risk.
"I want to send a message to consumers throughout the country: Buyer beware," Gregory D. Kutz, a GAO investigator, told the Senate Committee on Aging today.
Sen. Gordon Smith, R-Ore., chairman of the committee, was sharply critical of the home tests: "Clearly consumers are being misled and exploited by this modern-day snake oil and I am shocked to learn how little the federal government is doing to help consumers make informed decisions about the legitimacy of these tests."
Investigation's Findings
The tests cost up to $325 and may instill unwarranted fear about impeding illnesses without evidence, said the report.
In some cases, they appear to serve as an avenue for marketing expensive supplement pills, says the report.
For its investigation, the GAO bought 14 test kits from four U.S. companies and returned them along with diet and lifestyle questionnaires.
But the DNA samples used to create the 14 fake customers came from just two people: a 9-month-old girl and a 42-year-old male.
All of the samples came back alerting the 'consumers' they were at increased risk for everything from osteoporosisosteoporosis to a "reduced ability to clear toxins," the report says.
Challenges for Consumers
Genetic tests can predict a narrow range of diseases, including cystic fibrosiscystic fibrosis and Huntington's disease. But, the GAO said, genetic testing experts say links between gene mutations and most diseases are unproven.
In another part of the investigation, four DNA samples from the same individual garnered four different health recommendations from the companies, "clearly showing the results are based on the questionnaire" and not genetic information, Kutz said.
While analyzing labs are regulated by the government, no federal standards govern quality or reliability of tests.
"It's not possible for consumers to determine whether the tests are bogus or based on real science," said Kathy Hudson, PhD, director of the Genetics and Public Policy Center at Johns Hopkins University.
Industry Reaction
Howard Coleman, CEO of Seattle-based Genelex, Corp., one of the companies making home-based DNA tests, told the committee the tests "can be useful" to consumers.
"This helps them make the diet and lifestyle changes they need to do," he said.
Coleman and other company representatives said they would support efforts to more closely regulate genetic tests.
Tests are typically returned urging lifestyle advice, such as diet modification or exercise.
Those purchased from a company called Market America were returned to investigators with advice to use tailored dietary supplements, presumably to reduce disease risk, the GAO said. The supplements, on sale for $1,200, were very similar to multivitamins sold over-the-counter at drug stores.
Rosalynn Gill-Garrison, chief science officer of Sciona, a DNA test kit firm based in Boulder, Colo., says the company does not inappropriately warn customers they are at risk for diseases.
"We stop where the science stops," she said.
The GAO report accused Sciona and other companies of misleading consumers by using ambiguous language alerting them they may face an increased chance of illnesses.
Smith, largely unmoved by the firms' testimony, warned that Congress may soon place stricter rules on genetic tests and such company claims.
"I'm very alarmed that consumers are being preyed upon," he said.
SOURCES: Government Accountability Office, "Nutrigenetic Testing: Tests Purchased from Four Web Sites Mislead Consumers," July 27, 2006. Gregory D. Kutz, managing director, Forensic Audits and Special Investigations, GAO. Kathy Hudson, PhD, director, Genetics & Public Policy Center, Johns Hopkins University. Sen. Gordon Smith, R-Ore. Howard Coleman, CEO, Genelex Corp. Rosalynn Gill-Garrison, chief science officer, Sciona.