CLINICAL PRACTICE

Practice Guidelines

Clinical Practice Guidelines and Reports

AMP Clinical Practice Guidelines and Reports are developed to be of assistance to laboratory and other health care professionals by providing guidance and recommendations for particular areas of practice. The Guidelines or Report should not be considered inclusive of all proper approaches or methods, or exclusive of others. The Guidelines or Report cannot guarantee any specific outcome, nor do they establish a standard of care. The Guidelines or Report are not intended to dictate the treatment of a particular patient. Treatment decisions must be made based on the independent judgment of health care providers and each patient’s individual circumstances.

AMP makes no warranty, express or implied, regarding the Guidelines or Report and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. AMP shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein.

 

 

 

 

 

Recently Published Guidelines and Reports

Considerations for SARS-CoV-2 Genomic Surveillance: A Joint Consensus Recommendation of the Association for Molecular Pathology and Association of Public Health Laboratories. Released online ahead of publication in the Journal of Molecular Diagnostics.

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DPYD Genotyping Recommendations: A Joint Consensus Recommendation of the Association for Molecular Pathology, American College of Medical Genetics and Genomics, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, Pharmacogenomics Knowledgebase, and Pharmacogene Variation Consortium. Published in the October 2024 issue of the Journal of Molecular Diagnostics.

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Recommendations for Tumor Mutational Burden Assay Validation and Reporting: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, and Society for Immunotherapy of Cancer. Published in the August 2024 issue of the Journal of Molecular Diagnostics.

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Slice Testing - Considerations from Ordering to Reporting: A Joint Report of the Association for Molecular Pathology, College of American Pathologists, and National Society of Genetic Counselors. Published in the March 2024 issue of the Journal of Molecular Diagnostics.

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Recommendations for Cell-free DNA Assay Validations: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists. Published in the December 2023 issue of the Journal of Molecular Diagnostics.

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Exploring the Utility of Multiplex Infectious Disease Panel Testing for Diagnosis of Infection in Different Body Sites: A Joint Report of the Association for Molecular Pathology, American Society for Microbiology, Infectious Diseases Society of America, and Pan American Society for Clinical Virology. Published in the December 2023 issue of the Journal of Molecular Diagnostics.

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CYP3A4 and CYP3A5 Genotyping Recommendations: A Joint Consensus Recommendation of the Association for Molecular Pathology, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmacogenomics Knowledgebase. Published in the September 2023 issue of the Journal of Molecular Diagnostics.

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Recommendations for Next-Generation Sequencing Germline Variant Confirmation: A Joint Report of the Association for Molecular Pathology and National Society of Genetic Counselors. Published in the July 2023 issue of the Journal of Molecular Diagnostics.

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Assessments of Somatic Variant Classification Using the Association for Molecular Pathology/American Society of Clinical Oncology/College of American Pathologists Guidelines: A Report from the Association for Molecular Pathology. Published in the February 2023 issue of the Journal of Molecular Diagnostics.

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Recommendations for the Use of in Silico Approaches for Next Generation Sequencing Bioinformatic Pipeline Validation: A Joint Report of the Association for Molecular Pathology, Association for Pathology Informatics, and College of American Pathologists. Published in the January 2023 issue of the Journal of Molecular Diagnostics.

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TPMT and NUDT15 Genotyping Recommendations: A Joint Consensus Recommendation of the Association for Molecular Pathology, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmacogenomics Knowledgebase. Published in the October 2022 issue of the Journal of Molecular Diagnostics.

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An Educational Assessment of Evidence used for Variant Classification: A Report of the Association for Molecular Pathology. Published in the June 2022 issue of the Journal of Molecular Diagnostics.

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Electronic Health Records and Genomics: Perspectives from the Association for Molecular Pathology Electronic Health Record (EHR) Interoperability for Clinical Genomics Data Working Group. Published in the January 2022 issue of the Journal of Molecular Diagnostics.

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Recommendations for Clinical CYP2D6 Genotyping Allele Selection: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, and European Society for Pharmacogenomics and Personalized Therapy. Published in the September 2021 issue of the Journal of Molecular Diagnostics.

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Recommendations for Clinical Warfarin Genotyping Allele Selection: A Report of the Association for Molecular Pathology and College of American Pathologists. Published in the July 2020 issue of the Journal of Molecular Diagnostics.

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Recommendations for Clinical CYP2C9 Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists. Published in the September 2019 Issue of the Journal of Molecular Diagnostics.

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Clinical Significance of DNA Variants in Chronic Myeloid Neoplasms: A Report of the Association for Molecular Pathology. Published in the November 2018 Issue of the Journal of Molecular Diagnostics.

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Recommendations for Clinical CYP2C19 Genotyping Allele Selection: A Report of the Association For Molecular Pathology. Published in the May 2018 issue of the Journal of Molecular Diagnostics.

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Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Published in the March 2018 Issue of the Journal of Molecular Diagnostics.

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Standards and Guidelines for Validating Next-Generation Sequencing Bioinformatics Pipelines: A Joint Recommendation of the Association for Molecular Pathology and the College of American Pathologists. Published in the January 2018 Issue of the Journal of Molecular Diagnostics

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Guidelines for Validation of Next-Generation Sequencing-Based Oncology Panels. A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists. Published in the May 2017 Issue of the Journal of Molecular Diagnostics.

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Molecular Biomarkers for the Evaluation of Colorectal Cancer. Guideline from the American Society of Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology. Published in the March 2017 Issue of the Journal for Molecular Diagnostics.
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Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer: A Joint Consensus Recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists. Published in the January 2017 issue of the Journal of Molecular Diagnostics.

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Previous Guidelines and Reports

Emerging and Future Applications of MALDI-TOF Mass Spectrometry in the Clinical Microbiology Laboratory: A Report of the Association for Molecular Pathology. Published in the November 2016 issue of The Journal of Molecular Diagnostics.

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The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer. Published in the September 2016 issue of The Journal of Molecular Diagnostics.

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Next-Generation Sequencing for Infectious Disease Diagnosis and Management: A Report of the Association for Molecular Pathology. Published in the November 2015 issue of The Journal of Molecular Diagnostics.

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Do Circulating Tumor Cells, Exosomes and Circulating Nucleic Acids Have Clinical Utility for Molecular Pathologists? A Report of the Association for Molecular Pathology. Published in the May 2015 issue of The Journal of Molecular Diagnostics.

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Standards and guidelines for the interpretation of sequence variants: a joint consensus recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Published in the March 2015 issue of Genetics in Medicine.

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Reporting Incidental Findings in Genomic Scale Clinical Sequencing: A Clinical Laboratory Perspective: A Report of the Association for Molecular Pathology. Published in the March 2015 issue of The Journal of Molecular Diagnostics.

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Laboratory Practice Guidelines for Detecting and Reporting JAK2 and MPL Mutations in Myeloproliferative Neoplasms: A Report of the Association for Molecular Pathology. Published in the November 2013 issue of The Journal of Molecular Diagnostics.

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The Role of MGMT Testing in Clinical Practice: A Report of the Association for Molecular Pathology. Published in the September 2013 issue of The Journal of Molecular Diagnostics.

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Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors (April 2013). Developed jointly by the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP).

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Opportunities and Challenges Associated with Clinical Diagnostic Genome Sequencing: A Report of the Association for Molecular Pathology. Published in the November 2012 issue of The Journal of Molecular Diagnostics.

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Relevance, Pathogenesis, and Testing Algorithm for Mismatch Repair-Defective Colorectal Carcinomas: A Report of the Association for Molecular Pathology. Published in the March 2012 issue of The Journal of Molecular Diagnostics.

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