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Pathology, Molecular. --- Pathology, Molecular --- Molecular Diagnostic Techniques.
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The aim of this textbook of molecular imaging is to provide an up to date review of this rapidly growing field and to discuss basic methodological aspects necessary for the interpretation of experimental and clinical results. Emphasis is placed on the interplay of imaging technology and probe development, since the physical properties of the imaging approach need to be closely linked with the biologic application of the probe (i.e. nanoparticles and microbubbles). Various chemical strategies are discussed and related to the biologic applications. Reporter-gene imaging is beeing addressed not only in experimental protocols, but also first clinical applications are discussed. Finally, strategies of imaging to characterize apoptosis and angiogenesis are described and discussed in the context of possible clinical translation.
Diagnostic Imaging --- Diagnostic imaging. --- Molecular Diagnostic Techniques --- Molecular diagnosis. --- methods. --- methods.
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Molecular diagnosis. --- Pathology, Molecular. --- Pathology, Molecular --- Molecular Diagnostic Techniques --- Precision Medicine
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Pathology, Molecular. --- Pathology, Molecular --- Pathology, Molecular --- Molecular Diagnostic Techniques. --- Pathology, Molecular.
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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.
Molecular Diagnostic Techniques --- Laboratory Proficiency Testing --- Government Regulation --- standards. --- United States
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Basic Sciences. Biotechnology --- Biotechnology --- Biotechnology. --- Molecular Diagnostic Techniques. --- Molecular diagnosis. --- Nanotechnology --- Nanotechnology. --- Biotechnology (General). --- methods. --- methods.
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Nucleic acids --- Molecular Diagnostic Techniques --- Nucleic Acids --- Genetic Techniques --- Clinical Laboratory Techniques
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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.
Molecular Diagnostic Techniques --- Laboratory Proficiency Testing --- Government Regulation --- standards. --- United States
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Biomolecules --- Molecular Diagnostic Techniques --- Quality Control. --- Reproducibility of Results. --- Analysis --- Research --- Methodology --- Measurement --- standards. --- Biophysics
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