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Quality, regulation, and clinical utility of laboratory-developed molecular tests / ECRI Institute Evidence-Based Practice Center ; Fang Sun [and five others].
- Format:
- Book
- Government document
- Author/Creator:
- Sun, Fang, M.D., author.
- ECRI Evidence-based Practice Center, author.
- Series:
- Technology assessment (Agency for Healthcare Research and Quality).
- NCBI Bookshelf.
- Technology assessment report
- NCBI Bookshelf
- Language:
- English
- Subjects (All):
- Molecular Diagnostic Techniques--standards.
- Laboratory Proficiency Testing.
- Government Regulation.
- United States.
- Medical Subjects:
- Molecular Diagnostic Techniques--standards.
- Laboratory Proficiency Testing.
- Government Regulation.
- Physical Description:
- 1 online resource (1 PDF file (viii, 205 pages)) : illustrations.
- Place of Publication:
- Rockville, Maryland : Agency for Healthcare Research and Quality, May 9, 2010.
- Summary:
- The Coverage and Analysis Group at the Centers for Medicare & Medicaid Services (CMS) requested from The Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ) a horizon scan to summarize the available scientific evidence on the quality of laboratory-developed ("home brew" or "in-house") molecular tests, which are currently not actively regulated by the U.S. Food and Drug Administration (FDA). CMS has concerns about the quality of laboratory-developed tests and the validation currently being performed on these tests. AHRQ assigned this report to the following Evidence-based Practice Center (EPC): ECRI EPC (Contract Number: 290 2007 10063 I). To help CMS to address its concerns, this horizon scan is intended to: 1. identify types of laboratory-developed molecular tests (LDMTs) currently available for conditions relevant to the Medicare over-65-year-old population; 2. identify the methodologies and the processes that have been developed for the assessment of analytical and clinical performance of molecular tests; 3. summarize the role of Federal agencies in regulating LDMTs; and 4. identify the quality standards that have been developed for molecular tests by regulatory bodies, the industry, and the medical community.
- Notes:
- "Project ID LABC0707."
- Description based on version viewed June 8, 2015.
- Includes bibliographical references.
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