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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD, today announced the filing of a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that regulates laboratory developed test (LDT) procedures as medical devices under the Federal Food, Drug, and Cosmetic Act.

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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, today announced the recipients of this year’s Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership, and Meritorious Service Awards. These prestigious accolades will be presented to the winners this November during AMP’s 2024 Annual Meeting & Expo in Vancouver, British Columbia.

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The manuscript, “DPYD Genotyping Recommendations: A Joint Consensus Recommendation of the AMP, American College of Medical Genetics and Genomics (ACMG), Clinical Pharmacogenetics Implementation Consortium (CPIC), College of American Pathologists (CAP), Dutch Pharmacogenetics Working Group (DPWG) of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy (ESPT), Pharmacogenomics Knowledgebase (PharmGKB®), and Pharmacogene Variation Consortium (PharmVar),” was released online ahead of publication in The Journal of Molecular Diagnostics.

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The Association for Molecular Pathology (AMP) has published a set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing as a potential predictive biomarker for immune checkpoint inhibitor (ICI) therapies. These recommendations encompass pre-analytical, analytical, and post-analytical factors of TMB analysis, and emphasize the importance of comprehensive methodological descriptions in publications to allow comparability between assays.

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The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, will host a free webinar on the US Food and Drug Administration (FDA) final rule that seeks to regulate laboratory developed tests (LDTs) as medical devices.

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The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today released the results of its Impacts of the European Union (EU) In Vitro Diagnostic Regulation (IVDR) Survey. The anonymous survey was created and administered to molecular diagnostics professionals around the world to determine current levels of understanding, assess broad implications, and identify future trends related to the new regulation.

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The Association for Molecular Pathology (AMP) has published a report that explores specific considerations for a slice testing strategy for diagnostics, including gene selection, analytic performance, coverage, quality, and interpretation.

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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, today announced the appointment of Lauren S. Menser, CAE, as its Chief Executive Officer, effective January 3, 2024.

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The Association for Molecular Pathology has published best practice recommendations for validating and reporting clinical circulating tumor DNA (ctDNA) or liquid biopsy assays and their related scientific publications.

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The Association for Molecular Pathology (AMP) has announced the recipients of this year’s Award for Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership Award and Meritorious Service Award.

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The Association for Molecular Pathology (AMP) has published a review of the current benefits and challenges to using multiplex PCR panels for the detection of microbial pathogens from gastrointestinal, central nervous system, lower respiratory tract, and joint specimens.

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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, today published consensus recommendations to aid in the design and validation of clinical CYP3A4 and CYP3A5 genotyping assays, promote standardization of testing across different laboratories, and improve patient care.

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The Association for Molecular Pathology (AMP) today awarded Xavier Becerra, US Secretary of the Department of Health and Human Services, with its Champion for Innovation Award. Secretary Becerra was recognized for his 30-year career in public service and his ongoing commitment to protecting patient access to high-quality, affordable care. The award presentations coincides with the 10th anniversary of the Supreme Court’s landmark decision invalidating gene patents in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al.

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The Association for Molecular Pathology (AMP) has published a report that was designed to establish recommendations for standardizing orthogonal confirmation practices for germline variants detected by next-generation sequencing (NGS) in The Journal of Molecular Diagnostics.

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The Association for Molecular Pathology (AMP) applauds Congress for reaching an agreement on the Consolidated Appropriations Act of 2023 and recognizing that it was not the appropriate mechanism for advancing the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The VALID Act proposed dramatic oversight modifications that would have been disruptive to clinical testing laboratories and harmful to patients throughout the U.S.

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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, has published a report that was designed to assess clinical adoption, identify classification inconsistencies, and evaluate implementation barriers for the 2017 report, “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.” The AMP manuscript, “Assessments of Somatic Variant Classification Using the AMP/ASCO/CAP Guidelines” was released online ahead of publication in The Journal of Molecular Diagnostics.

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The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, has published “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.”

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The Association for Molecular Pathology (AMP), the premier global, molecular diagnostics professional society, today announced the recipients of this year’s Award for Excellence in Molecular Diagnostics, Jeffrey A. Kant Leadership Award and Meritorious Service Award. These prestigious accolades will be presented this November during AMP’s 2022 Annual Meeting & Expo in Phoenix, Arizona.

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The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, today published consensus recommendations to aid in the design and validation of clinical TPMT and NUDT15 genotyping assays, promote standardization of testing across different laboratories and improve patient care.