March 10, 2006

The Genetic Alliance asks for Sanity in the HHS on Genetic Testing

Karen Greendale turned us on to this recent release from the Genetic Alliance calling for a Genetic Testing Specialty under CLIA:
In a letter to Dr. McClellan, Genetic Alliance President and CEO, Sharon Terry, writes on behalf of her board: “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.”

In 2000, the Centers for Disease Control and Prevention (CDC) released a Notice of Intent that 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. In the time since that Notice of Intent was issued, the number of genetic tests available has grown significantly.

Today, there are more than 900 diseases for which genetic tests are clinically available, several hundred tests used in research, and even more in various stages of development. The Genetic Alliance board of directors 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.

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