CLSI MM23 : 1ED 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
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