CLSI MM23 : 1ED 2015
Current
The latest, up-to-date edition.
MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS)
Hardcopy , PDF
English
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
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