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CLSI MM23 : 1ED 2015

Current
Current

The latest, up-to-date edition.

MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-28-2015

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Biomarker Identification and Test
            Development Process
Chapter 3 - Biomarker Detection Testing Process
Chapter 4 - Quality System Essentials for Molecular
            Diagnostic Methods for Solid Tumors
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Appendix A - US Food and Drug Administration
             Guidance and Information
Appendix B - Examples of Human Cell Lines With
             Tumor-Specific Variants
Appendix C - Examples of a sample Requisition Form
The Quality Management System Approach
Related CLSI References Materials

Includes the current state of molecular diagnostic techniques intended for the characterization of solid tumors, and covers a range of clinical applications including diagnosis, prognosis, therapeutic response prediction for available drugs and those still in clinical trials, as well as monitoring and presymptomatic and predisposition testing.

This guideline describes the development and implementation of nucleic acid biomarker assays for accurate detection of somatic and germline alterations with applications to clinical decision making in oncology.

DocumentType
Standard
ISBN
1-56238-900-9
Pages
132
PublisherName
Clinical Laboratory Standards Institute
Status
Current

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