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Probe finds personalized DNA tests are misleading

WASHINGTON - A government investigator told members of Congress yesterday that personalized DNA tests claiming to predict certain inheritable diseases are misleading and offer little or no useful information.

An undercover investigation by the Government Accountability Office found that four genetic testing companies delivered contradictory predictions based on the same person's DNA.

Investigators also found that test results often contradicted patients' actual medical histories.

"Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science," said GAO investigator Gregory Kutz, in testimony before a House Energy and Commerce Subcommittee.

The GAO presented its findings at a Congressional hearing to scrutinize the personalized genetic industry, which until recently operated below the radar of federal regulators.

Genomic testing companies market saliva-based kits designed to detect whether individuals are genetically predisposed to get certain inheritable diseases like breast cancer or Alzheimer's disease. Such tests have been sold online for years, but they began attracting federal scrutiny in May when Pathway Genomics announced plans to market its products in retail pharmacies.

That plan was scuttled by the Food and Drug Administration, which said the tests must undergo federal testing.

The chief executive of Pathway testified alongside counterparts from Navigenics and 23andMe, saying their companies used the latest technology to give consumers insight into their genetic makeup.

But the GAO report suggests the companies still have a long way to go in drawing accurate conclusions.

Kuntz told lawmakers that the tests don't constitute fraud because the companies believe in the accuracy of their methods - but they should still be subject to regulatory standards.

According to the companies, the disparate results reported by GAO are a result of different analytical methods used by each company.

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