Consumer gene test results misleading: U.S. probe

People who send off their saliva to genetic testing companies to find out their risk for prostate cancer or diabetes are likely to get different results, depending on the company they choose, government investigators told lawmakers on Thursday.

Their undercover investigation of four unnamed genetic testing companies, in which five people sent away their DNA for testing, showed that the tests produced inconsistent results for the same disease 68 percent of the time.

Four out of five donors got test results that conflicted with their actual medical conditions and family histories.

The tests the GAO studied ranged from $300 to $1,000.

"Assuming these tests are credible, one would expect that identical DNA would receive identical predictions," Gregory Kutz of the Government Accountability Office said in prepared testimony before a U.S. House of Representatives panel investigating direct-to-consumer genetic tests.

Kutz told the panel, a subcommittee of the House Committee on Energy and Commerce, that the test companies use deceptive marketing practices and said the results "are misleading and of little use to consumers."

Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, said his agency is preparing to regulate the sale of these tests, which are offered by companies such as Navigenics Inc, Pathway Genomics Corp and 23andMe Inc, which is backed by Google Inc.

Shuren said the agency has sent letters to Pathway Genomics, Knome Inc, Navigenics Inc, deCODE Genetics and 23andMe - all of which have been selling their tests directly to consumers - informing them of the move to regulate them.

MEDICAL DEVICE

He said products by all five of these companies, in his view, meet the definition of a medical device, based on the companies' claims about their test results.

For more than three decades, the FDA has chosen not to regulate simple diagnostic tests developed in individual laboratories. But it does regulate tests considered medical devices - which are used to diagnose disease or other conditions or to prevent disease.

This week, the FDA hosted a two-day meeting with experts and companies about how the agency should begin regulating lab-developed tests.

Shuren said the FDA plans to draft a framework for regulating lab-developed tests, which it will phase in based on the level of risk to patients.

None of the genetic tests now offered directly to consumers has been cleared by the FDA to ensure the results are "accurate, reliable and clinically meaningful," he said.

Shuren said the FDA has also sent a letter to Illumina Inc, a maker of genetic testing equipment, for "supplying unapproved reagents and instrumentation" labeled for research purposes to direct-to-consumer testing companies.