AMP Releases Best Practice Recommendations to Guide Clinical Laboratories Offering HRD Testing

This deficiency is often linked to increased genomic instability and serves as a potential biomarker for predicting response to certain cancer therapies.

Although multiple HRD assays are currently available, they differ in their definitions of HRD, the biomarkers they assess, and the algorithms they employ. These variations can impact treatment decisions, especially for patients who may benefit from poly (ADP-ribose) polymerase (PARP) inhibitor therapies. To address this issue, the Association for Molecular Pathology (AMP, Rockville, MD, USA), the premier global molecular diagnostic professional society, has published its best practice recommendations for clinical laboratories developing and performing HRD testing.

To develop these recommendations published in The Journal of Molecular Diagnostics, AMP’s Clinical Practice Committee assembled an expert panel to review current practices and assess the medical literature related to the molecular detection of HRD in clinical settings. The AMP Detection of HRD in Cancer Working Group included organizational representation from the Association of Community Cancer Centers, the American Society of Clinical Oncology, and the College of American Pathologists.

The AMP HRD Working Group developed 12 recommendations focused on the design and validation of HRD assays. These guidelines are based on survey data, a review of more than 4,300 peer-reviewed scientific publications, professional experience, and consensus of the subject matter experts. The recommendations address technical aspects of genomic instability and HRD analysis, including interpretation of genomic scars from tumor and germline next-generation sequencing results and the clinical relevance of HRD biomarkers.

“As part of our assessment, we identified considerable variability in many aspects of HRD testing, including sample requirements, tumor types, molecular methodologies and the biomarkers evaluated,” said Alanna J. Church, M.D., is the chair of AMP’s 2025 Clinical Practice Committee and associate director of the Laboratory for Molecular Pediatric Pathology at Dana-Farber/Boston Children’s Cancer Center. “This new report offers evidence-based recommendations for HRD diagnostic assays to help improve standardization, transparency, quality across laboratories and care for our cancer patients.”

“These recommendations are intended to guide clinical laboratories offering HRD testing and highlight areas where further research and validation are needed,” added Susan Hsiao, M.D., Ph.D., is the chair of the AMP Detection of HRD in Cancer Working Group and associate professor of pathology and cell biology at Columbia University Vagelos College of Physicians and Surgeons. “AMP remains committed to refining these recommendations as scientific knowledge and technology continue to evolve.”

Related Links:
AMP