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Critical Findings from Friends HRD Harmonization Project

Critical Findings from Friends HRD Harmonization Project

Homologous Recombination Deficiency (HRD) is a complex biomarker that can help identify patients likely to respond to certain therapies. Friends of Cancer Research’s (Friends) HRD Harmonization Project Harmonization Project is a unique research partnership to find alignment among different assays that measure HRD, to support its use as a biomarker in clinical research and care, and to serve as a foundational approach to inform future areas of research.

Friends worked with leading diagnostic test developers and other key stakeholders to evaluate a common set of tumor samples. The project assessed variability across 17 different HRD tests and identified opportunities for future alignment.  

View initial findings here

Optimizing assay alignment improves interpretation of HRD outputs from different tests, ultimately helping patients and healthcare providers to make the best treatment decisions. 

A panel discussion with project partners during Friends recent public meeting, “The Future of Diagnostic Tests: New Data & Modern Policy” held in Washington, DC and broadcast virtually focused on findings from the research partnership and their implications. The session, “Aligning on Approaches to Measuring HRD: Findings from the HRD Harmonization Project,” opened with a presentation from Friends’ Director, Regulatory and Research Partnerships, Hillary Andrews, discussing the intricacies of HRD as a biomarker and noting its significance in identifying patients suitable for a PARP inhibitor, a type of targeted cancer drug used as a treatment across various cancers.  

She also described the final findings from the project, demonstrating moderate variability among HRD outputs across 17 assays that assessed a common dataset. Click to watch the full meeting

Dr. Andrews’ presentation was followed by a panel conversation with Project work group members. This diverse set of panelists spoke to the recent developments within the project and next steps.  

One of the key take aways from the discussion is the need for assay alignment. This was addressed early on in the conversation by NCI project partner Lisa McShane. 

This importance of assay development and assay alignment segway into the role that providers play in supporting the work to reach a gold standard. Project partner Rebecca Arend at the University of Alabama Birmingham spoke to the implications of not having further develop assay alignment on doctors and patients. 

This critical point reaffirmed why continued work communicating and creating consistency in assay development is vital. 

An exciting recent development within the field is the application of machine-based learning. This was a closing remark from Pfizer’s Douglas Laird as we look to the future use cases of HRD. 

The HRD Harmonization Project serves as a foundation to support future research to: 

Project Partners

ACT Genomics, AmoyDx, AstraZeneca, Bayer, Bionano Genomics, Inc., BostonGene Corporation, Bristol Myers Squibb, Burning Rock, Diagnostic Laboratory Services, Inc., DNAnexus, EMD Serono, Inc., European Organization for Research and Treatment of Cancer (EORTC), Foundation Medicine, Inc., Genentech, Inc., Guardant Health, Inc., Illumina, Inc., Invitae Corp., Laboratory Corporation of America (Labcorp), MD Anderson Cancer Center, Merck & Co., Inc. (MSD), Molecular Characterization Laboratory (MoCha) at Frederick National Laboratory, the National Cancer Institute (NCI), NeoGenomics Neogenomics Laboratories, Inc., PathAI, Pfizer, Pillar Biosciences, SOPHiA Genetics, Tempus, Thermo Fisher Scientific, the U.S. Food and Drug Administration (FDA), University of Alabama at Birmingham, and the University of Heidelberg.


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