* Investigation finds tests produced inconsistent results
* FDA says tests should be accurate
* Agency to prepare a ‘framework’ for regulating tests (Adds company comment in paragraph 16)
By Julie Steenhuysen
CHICAGO, July 22 (Reuters) - 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 (GOOG.O).
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.
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. [ID:nN2098257]
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 (ILMN.O), a maker of genetic testing equipment, for “supplying unapproved reagents and instrumentation” labeled for research purposes to direct-to-consumer testing companies.
All six companies have been asked to meet with the FDA to discuss the regulatory status of their products.
23andMe Inc said in a statement that the GAO had refused to discuss its report with the company.
“We are confident in our service’s accuracy, reliability and value. However, we embrace the ideas that the FDA offered today and look forward to helping to develop a regulatory framework that provides standards and transparency across the industry,” it said.
Shuren said the FDA has been watching the activity of companies selling genetic tests directly to consumers for some time, but grew concerned with the “aggressive” marketing practices of Pathway Genomics, which had announced a pact with Walgreen Co WAG.N in April to distribute its tests through its network of more than 6,000 neighborhood pharmacies.
Pathway has since stopped selling its tests directly to consumers.
Representatives from Pathway, 23andMe and Navigenics defended their tests before the panel, saying they are useful in helping consumers change their habits to help avoid problems like diabetes.
But Dr. James Evans of the University of North Carolina, who advised the GAO, told the panel they are of little use to consumers.
“No one knows how to interpret these data. That is quite clear,” he said. (Editing by Xavier Briand)