HRD Harmonization Project
Project Updates: Phase 1 Results to be announced soon, Phase 2 Launching
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The Definition: Homologous recombination deficiency (HRD) is a complex biomarker that helps identify whether patients may respond to certain treatments.
This type of biomarker has promise in identifying patients with certain cancers who are more likely to benefit from PARP inhibitors and additional DNA repair targeting drugs.
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The Problem: Currently, there is no standardized way to define, measure, and report HRD.
A few NGS-based HRD assays are currently available, and these use different approaches to measure HRD. But there is no agreement on what parameters contribute to the determination of a sample’s HR status (e.g., HRD or HR-proficient).
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The Solution: A unique research partnership to develop alignment strategies among different methods for measuring HR status and aligning around its use as a biomarker in clinical care.
Friends has assembled a consortium of project partners from key healthcare sectors to address concerns about the lack of consistency in determining HR status, its prognostic value, and its use as a predictive biomarker.
Given the improved outcomes associated with patients whose tumors display characteristics of HRD, it is vital to understand what should be measured, how to achieve alignment on how HRD is measured, and its performance as a biomarker for treatment efficacy.
HRD Harmonization Project Timeline
The HRD Harmonization Project will be broken down into three phases. Phase 1 is currently nearing completion and consists of a landscape analysis on the current practices in the field regarding HRD. Phase 2, which is currently underway, will aim to characterize HRD assays. Once Phase 2 is nearing completion, Phase 3 will then seek to propose harmonized approaches for generating meaningful clinical evidence.
By the end of phase 1, the consortium aims to have agreement on the definition of HRD and the parameters that contribute to the determination of HR status (HRD or HR-proficient). Additionally, the consortium will create recommendations and best practices to benefit the entire cancer community.
Results from Phase 1 of the HRD Harmonization Project are slated to be released by the 3rd quarter of 2021.
To read more about the project, please click HERE to view our project press release.
To sign up for updates on the HRD Harmonization Project, click HERE.
HRD Harmonization Project Phase 2 Working Group Members
ACT Genomics, Amoydx, AstraZeneca, Bayer, Biodiscovery, Bristol Myers Squibb, Caris Life Sciences, EMD Serono, EORTC, Foundation Medicine Inc., Frederick National Laboratory for Cancer Research, Guardant Health, Illumina, Independent, Invitae, Kaiser, MD Anderson, Merck, Myriad, the National Cancer Institute (NCI), Neogenomics, OHSU Knight Cancer Institute, Omniseq, Optum, Personalis, Pfizer, Q2 Solutions, Qiagen, SOPHiA Genetics, Tempus, Thermo Fisher Scientific, University of Alabama at Birmingham, University of Heidelberg, and the U.S. Food and Drug Administration.
HRD Harmonization Project Phase 1 Working Group Members
Abbvie, ACT Genomics, Ambry Genetics, AstraZeneca, Arizona State University, Bristol Myers Squibb, Caris Life Sciences, EMD Serono, Foundation Medicine, GlaxoSmithKline, Guardant Health, Janssen, Merck, Myriad, the National Cancer Institute, Novartis, Pfizer, Resolution Biosciences, Tempus, Thermo Fisher, University of Alabama at Birmingham, University of Heidelberg, and the U.S. Food and Drug Administration.