The joint consensus recommendation from AMP, ASCO, and CAP addresses variability in molecular profiling report formats across laboratories.
The Association for Molecular Pathology (AMP) has published new best practice recommendations for presenting complex molecular profiling information to oncologists and other healthcare providers through a standardized biomarker report template.
The manuscript, titled “Developing Consensus for a More Provider-Friendly Next-Generation Sequencing Molecular Biomarker Report: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was published online ahead of print in The Journal of Molecular Diagnostics. The biomarker report template is available on AMP’s website.
While next-generation sequencing testing for solid tumors is increasingly available, its use has been limited due to widespread shortages of qualified clinical laboratory professionals and the complexities involved in data interpretation, according to a release from AMP. Most clinical laboratories produce their own report formats, which can vary significantly in terms of length and organization of results and other content.
“Oncologists who receive our molecular biomarker reports typically need to assess the clinical impact of specific somatic mutations, determine whether any available therapies target those mutations and evaluate the strength of supporting evidence in order to provide the best care for their patient,” says Alanna J Church, MD, chair of AMP’s 2025 Clinical Practice Committee and director of innovation in pediatric cancer genomics at Boston Children’s Hospital, in a release. “This new highly anticipated biomarker report template offers recommendations to help laboratories implement the presentation of complex molecular profiling data in a clear, yet guideline-concordant format specifically designed for oncologists and other healthcare providers.”
Multi-Organization Working Group
To address these issues, AMP’s Clinical Practice Committee convened a multidisciplinary panel of experts to create a simplified and consensus-driven biomarker report template that providers could review and utilize more effectively for patient care. The AMP Provider-Friendly Biomarker Report Working Group included representatives from AMP, the American Society of Clinical Oncology, and the College of American Pathologists.
The working group’s proposed report template was informed by the team’s clinical expertise and a review of 17 next-generation sequencing biomarker reports for solid tumors from public, private, and academic laboratories. The template also incorporates extensive community feedback from a public comment period.
The panel of experts assessed specific components, including overall report length, presence of a summary section and biomarker results table, use of color and formatting, therapeutic guidance, references to clinical practice guidelines, inclusion of clinical trial options, background information on biomarkers, assay and coverage details, and clear explanations of variants of uncertain significance.
Supporting Broader Next-generation Sequencing Adoption
“This joint consensus recommendation is intended to support broader use of [next-generation sequencing] testing and to help optimize patient care,” says Jane S Gibson, PhD, AMP president and lead author of the paper, in a release. Gibson is also a Pegasus-awarded professor of pathology, chair of the Department of Clinical Sciences, and director of molecular diagnostics at the University of Central Florida College of Medicine. “AMP is committed to revisiting and refining the report template as advances in science, technology, and clinical practice continue to evolve.”
The biomarker report project was supported by an unrestricted continuing medical education grant from AstraZeneca and Daiichi Sankyo.
AMP is hosting a webinar to provide additional details on the key aspects of the proposed provider-friendly report template. The webinar, “Developing Consensus for a More Provider-Friendly NGS Molecular Biomarker Report,” will be presented by Gibson and moderated by Anthony N Snow, MD, University of Iowa Hospitals and Clinics, on Thursday, Dec 18, at 2:30 pm ET.
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