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Print this pageWashington, DC - August 25, 2006 - Genetic testing has slipped though the cracks of federal regulation for far too long, argue Center Director Kathy Hudson and Director of Law and Policy Gail Javitt in a recent commentary. The article, which appears in the August 21 edition of the UK-based newsletter BioNews, cites a new report by the Government Accountability Office (GAO) as evidence that the Centers for Medicare and Medicaid Services (CMS) needs to act now to protect consumers.
“The GAO conducted an undercover ‘sting’ of companies selling so-called nutrigenomic tests directly to consumers,” the commentary explains. “Even though the DNA [GAO submitted] was identical, the genetic test results were not: Clearly, the labs were unable to reliably reach the same conclusions about the same DNA.” The report demonstrates the failure of current oversight to ensure that genetic tests are accurate, reliable, and relevant to a patient’s health, Hudson and Javitt write.
Responsibility for ensuring the analytic validity of genetic tests lies with the CMS, which implements the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the authors observe. Specifically, they say, CMS should create a long-awaited genetic testing specialty under CLIA.
While it would address analytic errors at genetic testing laboratories, the commentary notes, “fixing CLIA wouldn’t solve problems with clinical validity or misleading claims such as those the GAO report highlighted.” In fact, no federal agency has clear authority to mandate that sufficient scientific evidence supports a test’s relationship to health status. Hudson and Javitt conclude that a recent Senate hearing on direct-to-consumer genetic tests may finally “help overcome a decade of bureaucratic inertia,” and direct much-needed public attention to the problem.
Full citation: Hudson, K. and G. Javitt. "The case for genetic testing oversight." BioNews (2006) August 21.
For More Information Contact:
Rick Borchelt, 202.663.5978, rborche1@jhu.edu
Shawna Williams, 202.663.5979, swilliams114@jhu.edu
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