In a landmark advancement poised to transform molecular diagnostics in oncology, the Association for Molecular Pathology (AMP) has unveiled a novel set of best practice recommendations designed to enhance how intricate next-generation sequencing (NGS) molecular profiling data is conveyed to oncologists and healthcare providers. This pioneering consensus, established jointly with the College of American Pathologists (CAP), tackles one of the most pressing challenges limiting the broader clinical application of NGS testing in solid tumors: the heterogeneity and complexity of report formats that hinder effective data interpretation and clinical decision-making.
Despite the rapid proliferation of NGS techniques offering unprecedented depth in understanding tumor genomics, their routine utilization in clinical oncology has been impeded by a shortage of expertly trained laboratory professionals and the difficulty providers face when interpreting dense molecular data. Laboratories across the United States and worldwide have traditionally produced biomarker reports with varying degrees of detail, structure, and clarity, which risks misinterpretation or oversights in critical genomic findings. In response, AMP’s dedicated Clinical Practice Committee assembled a multidisciplinary working group, including representatives from AMP, CAP, and the American Society of Clinical Oncology (ASCO), to architect a streamlined, consensus-driven report template aimed at enhancing provider usability without compromising clinical rigor or guideline adherence.
At the heart of this initiative is a biomarker report template grounded in robust clinical expertise and empirical evaluation. The working group conducted an exhaustive review of 17 existing NGS biomarker reports for solid tumors, encompassing submissions from academic, private, and public sector laboratories. This comparative analysis informed core design decisions surrounding report length, the inclusion of summary sections, tabular presentations of molecular alterations, and the visual use of color coding and formatting elements intended to direct clinical focus intuitively. The template notably prioritizes therapeutic guidance, links to clinical practice guidelines, inclusion of relevant clinical trials, and transparent annotation of variants of uncertain significance (VUS) to empower oncologists with actionable, evidence-based insights.
This critically needed consensus was publicly vetted, incorporating broad feedback from clinical communities, a step that ensured the final recommendations reflect practical utility and address end-user needs. By standardizing the molecular biomarker report, AMP and its partners aim to dismantle existing barriers in NGS result communication, fostering a more cohesive and efficient integration of molecular profiling into personalized cancer therapy strategies.
Dr. Alanna J. Church, chair of AMP’s Clinical Practice Committee and a leader in pediatric cancer genomics at Boston Children’s Hospital, highlights the clinical imperative driving this endeavor. She emphasizes that oncologists must rapidly assess the clinical impact of detected somatic mutations, considering potential targeted therapy options along with the evidentiary strength supporting these interventions. “Our newly developed biomarker report template offers a carefully balanced, guideline-concordant format designed specifically to optimize oncologist engagement with complex molecular data, ultimately striving to improve patient care,” Dr. Church remarks.
The initiative underscores the necessity of refining molecular diagnostics to keep pace with evolving genomic technologies and the expanding repertoire of targeted therapeutics. AMP President Jane S. Gibson, Ph.D., who also spearheaded the publication of the consensus manuscript, reiterates the organization’s commitment to ongoing updates of the report template. As shifts in scientific understanding, technical capabilities, and clinical paradigms emerge, such living documents will remain critical to sustaining precision oncology’s momentum and maximizing the clinical impact of NGS testing.
Accompanying the publication of the manuscript in The Journal of Molecular Diagnostics is AMP’s provision of an accessible biomarker report template via its website, enabling laboratories to implement the recommendations expeditiously. Furthermore, AMP has scheduled a live webinar hosted by Dr. Gibson to elaborate on key elements and practical considerations inherent in the new report format, fostering adoption and dialogue within the molecular diagnostics community.
The genesis of this comprehensive consensus was supported through an unrestricted continuing medical education grant from AstraZeneca and Daiichi Sankyo, reflecting a collaborative commitment across industry and professional stakeholders to enhance molecular diagnostic services in oncology.
This pioneering template and its underlying recommendations represent a significant stride toward harmonizing how genomic data is communicated in cancer care, alleviating complexities that have historically complicated molecular test utilization. By prioritizing clarity, actionable content, and alignment with clinical practice guidelines, the report template is positioned to improve diagnostic accuracy, streamline clinical workflows, and ultimately inform more precise, personalized treatment decisions for oncology patients worldwide.
In sum, the collaborative effort between AMP, CAP, and ASCO encapsulates an essential evolution in molecular diagnostics. It addresses multifaceted challenges in NGS test reporting through a provider-centric lens, reinforcing the crucial nexus between molecular pathology and oncologic care. As the precision medicine landscape continues to expand complexity, such innovations in communication standards will be vital in translating genomic insights into tangible clinical benefit.
Subject of Research: Next-generation sequencing molecular biomarker report standardization in oncology
Article Title: Developing Consensus for a More Provider-Friendly Next-Generation Sequencing Molecular Biomarker Report
News Publication Date: October 8, 2025
Web References: https://doi.org/10.1016/j.jmoldx.2025.08.011
Keywords: molecular diagnostics, next-generation sequencing, oncology, molecular biomarker, clinical genomics, personalized medicine, cancer, pathology, diagnostic accuracy, genetic testing
