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CLSI MM23

Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd Edition

CLSI MM23 covers the current state of molecular diagnostic methods intended for characterization of solid tumors and covers a range of clinical applications, including diagnosis, prognosis, therapeutic response prediction for available drugs and drugs still in clinical trials, monitoring, and presymptomatic and predisposition testing.

This document is available in electronic format only.

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Details

Chairholder: Lawrence Jennings, MD, PhD, D(ABHI), FCAP; Jason Merker, MD, PhD

Date of Publication: February 11, 2025

Order Code PDF: CLSI MM23Ed2E
ISBN Number: 978-1-68440-257-1

Order Code Print: print not available

Edition: Second

Pages: 126

CLSI MM23 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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CLSI MM23 Abstract

Clinical and Laboratory Standards Institute MM23—Molecular Diagnostic Methods for Solid Tumors (Nonhematologic Neoplasms) describes development and implementation of nucleic acid biomarker assays for accurate detection of somatic alterations, with applications to clinical decision-making for cancer patients with solid tumors. CLSI MM23 is intended for molecular diagnostic laboratory directors, industry laboratory professionals, health care professionals (including anatomic and clinical pathologists), manufacturers and developers, and regulatory and accreditation organizations. The methods and recommendations discussed in CLSI MM23 focus primarily on detection of tumor-specific (ie, somatic) genetic abnormalities that are acquired during tumorigenesis and that are distinct from normal variations in nonmalignant cells of the same tissue.