CLSI MM26

Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation, 1st Edition

CLSI MM26 focuses on strategies for use of effective communication and consultation channels with clinicians in addition to test utilization management to support improved diagnosis, treatment selection, and risk assessment to guide care for patients with cancer.

This edition of the document was corrected in October 2024. Read the correction notice by accessing the link above, and learn more about our corrections process here.

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Chairholder: Daniel Jones, MD, PhD; Honey V. Reddi, PhD, FACMG

Date of Publication: July 10, 2024

Order Code PDF: CLSI MM26Ed1E
ISBN Number: 978-1-68440-237-3

Order Code Print: print not available

Edition: First

Pages: 142

CLSI MM26 Additional Details

A CLSI report for global application.

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CLSI MM26 Abstract

Building, growing, and maintaining a molecular oncology testing laboratory involves extensive basic and applied knowledge in oncology, anatomic pathology, and laboratory medicine, and a diverse skill set in technical operations, test interpretation, and financial and regulatory topics. Clinical and Laboratory Standards Institute MM26—Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation reviews the current key concepts in molecular oncology, indications for testing, and laboratory and test design. It is intended to provide management personnel, particularly the laboratory director as well as technical and medical directors and pathologists, with practical and actionable information for strategic planning and daily laboratory operations. CLSI MM26 includes guidance focused on providing molecular oncology laboratory consultations to clinical providers and other stakeholders, including through molecular tumor boards. Emerging areas of testing such as liquid biopsy and identifying germline variants in cancer panels are also included. The infrastructure and best practices for data sharing of cancer genomic results and keeping the laboratory up-to-date with technologies and test development in the rapidly evolving areas of cancer genomics, such as single-cell sequencing and digital spatial profiling, are also discussed.