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Creating a Genetic Testing Specialty Under CLIA: What Are We Waiting For?

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Publication Date: January 2006

Publisher(s): Genetics and Public Policy Center

Author(s): Kathy Hudson; Gail Javitt; Juli Murphy

Funder(s): Pew Charitable Trusts

Funder(s): Pew Charitable Trusts

Topic: Health (Licensing and regulation)
Health (Medical research and technology)

Keywords: Oversight; Public policy; Genetic testing; Clinical Laboratories Improvements Amendments

Type: Report

Coverage: United States


This paper reviews the comments submitted in response to the NOI and identifies areas of consensus as well as areas of concern and opposition. It finds that there was support for key recommendations in the NOI, and recommends that CMS issue a proposed rule that focuses on these key issues, while leaving aside those that were more controversial and arguably less central to ensuring laboratory quality. Before reviewing the comments, however, it is necessary to place the NOI within the overall history and purpose of CLIA and the regulation of laboratory tests more generally.