Stronger Oversight of Gene Testing is Sought
By ANNA WILDE MATHEWS
May 2, 2008; Page B4
WASHINGTON -- A federal advisory panel called for tougher government oversight of the burgeoning genetic-testing business, warning that tests are being marketed with little evidence about their usefulness.
In a report released Thursday, the Secretary's Advisory Committee on Genetics, Health and Society said that all lab tests should be examined by the Food and Drug Administration and that genetic tests should be subject to the most stringent type of lab evaluation, known as proficiency testing.
The panel, which was reporting to the Department of Health and Human Services, also called for a mandatory registry of all laboratory tests. "There are plenty of tests out on the market now that have essentially had no scrutiny of any type," said Marc Williams, a member of the panel and the director of the Clinical Genetics Institute at Intermountain Healthcare in Salt Lake City.
The House Thursday passed a bill that will bar employers and insurers from discriminating based on genetic makeup, a move likely to encourage more use of genetic tests because people could be less concerned the results would be used against them. The long-stalled legislation, which passed 414-1, had won a unanimous Senate vote and is expected to get President Bush's signature.
The panel's report highlighted "gaps" in oversight, including a lack of evidence for how clinically useful many genetic tests actually are. A growing number are "inappropriately offered based on...studies that have not been adequately validated," it said.
At the federal level, labs are overseen primarily by the Centers for Medicare and Medicaid Services. The panel said the agency needed stronger and more direct enforcement power to go after labs that aren't properly certified.
In addition, the report said labs' execution of the tests should be more tightly monitored. The toughest proficiency checks are only required for 83 lab tests overall, based on a list devised in 1992, and there are now tests being offered for more than 1,500 genetic diseases. Ideally, all genetic tests should get the proficiency reviews, the committee wrote.
The clinical-laboratory industry has generally resisted a bigger FDA role, arguing that regulatory reviews like those required of pharmaceuticals would be too burdensome and slow for the emerging lab tests. Alan Mertz, president of the American Clinical Laboratory Association, said FDA reviews would be "overregulation."
The committee -- officials from industry, academia and government -- was to a degree echoing earlier conclusions by similar advisory groups. Guidelines that the FDA first proposed in September 2006, which would assert agency oversight over one category of genetic and protein-based tests, have remained stalled and were never finalized.
It is unclear how much traction the group's views will get during the remainder of the Bush administration. A spokeswoman for the Department of Health and Human Services said the agency appreciates the report and "will carefully consider its recommendations."
Still, regulation of genetic tests could move ahead more aggressively in a new administration, or with a more heavily Democratic Congress. Two bills that would increase oversight have been proposed, one co-sponsored by Democratic presidential candidate Sen. Barack Obama of Illinois, and the other by Democratic Sen. Edward Kennedy of Massachusetts.
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