In Brief: Clinical Laboratory Improvement Advisory Committee
This article was originally published in The Gray Sheet
Executive Summary
Clinical Laboratory Improvement Advisory Committee: Agenda to the Sept. 11-12 meeting in Atlanta, Georgia is amended to include discussion on "Physician-directed Home Use Tests" on Sept. 11. The Center for Disease Control is adding the topic to the agenda in light of FDA's recent approval of two prescription tests for use at home: International Technidyne's ProTime and Boehringer Mannheim's CoaguChek prothrombin time tests. CDC hopes to gather advice on whether prescription home-use tests meet CLIA waiver criteria. Also at the Sept. 11-12 meeting, the committee will discuss genetics testing, the quality of laboratory testing, access to health services and costs ("The Gray Sheet" Aug. 18, In Brief)...