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Overhaul of Genetic and Other Advanced Diagnostic Testing Regulations Necessary for Personalized Medicine, HHS Secretary Told
Date:5/5/2009

genetic testing oversight:

All advanced diagnostic tests - including both test kits and genetic tests developed in-house by the laboratory, which currently are subject to different levels of regulatory scrutiny under Food and Drug Administration (FDA) policies - should be regulated using consistent risk-based standards recognizing the unique aspects of each. Scientific capabilities at HHS and FDA may need to be enhanced and strengthened to accomplish this, the group notes.

Sebelius should establish a publicly accessible registry that includes the name of the laboratory performing a specific test, the name of the laboratory or company that developed the test, and information to support claims about the how useful the test is in obtaining the correct results and improving clinical care.

Oversight of clinical laboratory quality, currently tasked to the Centers for Medicare and Medicaid Services (CMS), should be strengthened to make sure that the information provided by genetic and other advanced diagnostic tests is accurate, reliable, and timely. FDA and CMS need to review their respective oversight roles to avoid unnecessary duplication, the letter advises.

The letter is remarkable for the breadth of its 108 signatories, according to Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, which has signed the document. "Many of us are more accustomed to being on opposite sides of the table when it comes to regulating genetic testing," she says. "The level of consensus here truly represents a watershed moment in laying this critical foundation for personalized medicine."

"The importance of this issue to patients is clear from the large number of patient advocacy groups who signed onto this letter," said Sharon Terry. Terry is the chief executive officer of the Genetic Alliance and a board member of the Coalition for 21st Century Med
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SOURCE The Coalition for 21st Century Medicine
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