Center calls for stronger federal regulation of genetic testing

(WASHINGTON, Nov. 29, 2005) The Genetics and Public Policy Center this week called on Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services (CMS), to end years of delay in assuring the safety and accuracy of genetic testing by issuing a proposed rule to create a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The delay has meant that scientific and technological advances in genetic testing have outpaced the government's ability to provide adequate oversight, maintains the Center, which was established by The Pew Charitable Trusts through Johns Hopkins University.

CMS, an agency of the U.S. Department of Health and Human Services, administers standards for diagnostic laboratory testing, such as those used for blood sugar, urinalysis, or HIV infection, to ensure that the tests are accurate and reliable and that physical conditions at the laboratories meet certain expectations.

"For more than ten years, federal advisory committees have been calling upon the government to provide more oversight of genetic tests," the letter to McClellan from the Center notes. CMS responded to the growing sense of urgency to improve genetic testing oversight five years ago by issuing a Notice of Intent of proposed rulemaking that incorporated recommendations from a federal advisory group regarding development of a genetic testing specialty.

"More than five years later, nothing has been issued by (CMS)," the letter says. During the same period, the genetic testing industry has grown dramatically; today, more than 800 genetics tests are available clinically, and many more are in development. "These genetic tests may be the basis for profound life decisions, such as whether to undergo prophylactic mastectomy, terminate a pregnancy, or take a certain drug or certain dosage of a drug," according to the letter.

Under CLIA, CMS is charged with developing standards for how medical la

Contact: Rick Borchelt
Genetics & Public Policy Center, Johns Hopkins University

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