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Genetic Alliance Calls for CMS to Regulate Genetic Tests Under CLIA

NEW YORK, March 3 (GenomeWeb News) - Public advocacy group Genetic Alliance is pressing the Centers for Medicare and Medicaid Services to set standards for genetic testing, the alliance said yesterday.

 

In a letter to CMS Administrator Mark McClellan, Genetic Alliance CEO Sharon Terry urged the agency to establish a genetic testing specialty under the Clinical Laboratory Improvemet Amendments, according to a statement from the alliance. CMS is responsible for implementing CLIA standards.

 

"The establishment of a genetic testing specialty under CLIA is a necessary first step toward a regulatory system that encourages new technology and ensures safety and accuracy when those technologies are implemented," Terry wrote in a statement. 

 

In 2000, the Centers for Disease Control and Prevention "indicated that CMS would issue a proposed rule to establish a genetic testing specialty area under CLIA. However, more than five years later no such specialty area exists," the statement reads. "In the time since that Notice of Intent was issued, the number of genetic tests available has grown significantly."

 

Genetic Alliance "believes that the establishment of a genetic testing specialty under CLIA will have a significant impact on the quality of genetic testing services in this country."

 

 "Without a genetic testing specialty, CLIA cannot adequately ensure that consumers receive genetic testing services that are safe, accurate, and clinically useful," Terry said.

 

The letter can be found  here.

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