QIAGEN and Myriad Genetics create global-use homologous recombination deficiency test

On May 30, 2024, QIAGEN and Myriad Genetics announced their partnership to develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status using next-generation sequencing (NGS) technology. This collaboration aims to facilitate research in personalized medicine for various solid tumors, including ovarian cancer, and enhance decentralized testing capabilities.

The HRD test will leverage QIAGEN’s QIAseq xHYB technology and QIAGEN Digital Insight solutions, combined with Myriad’s FDA-approved MyChoice CDx biomarkers. MyChoice CDx is a centralized testing service that evaluates HRD by analyzing a tumor’s DNA repair mechanisms, focusing particularly on BRCA1 and BRCA2 gene mutations. The test calculates a Genome Instability Score (GIS), aiding in the identification of ovarian cancer patients who may benefit from targeted therapies such as LYNPARZA® (olaparib) by AstraZeneca.

Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN, emphasized the partnership’s goal of expanding HRD test accessibility. This expansion is expected to expedite therapy decisions, reduce costs, and decrease turnaround times by minimizing the need for outsourced testing, thereby benefiting patients.

The MyChoice CDx assay is noted for its ability to identify 34% more tumors with HRD using the GIS score compared to other methods that only use percent loss of heterozygosity (%LOH). Approximately 48% of ovarian cancer tumors exhibit HRD, often due to specific mutations within the tumor. Expanding access to this assay is crucial for advancing personalized medicine and ensuring patients receive the most suitable treatments.

Patrick Burke, Executive Vice President of Strategy and Innovation at Myriad Genetics, expressed enthusiasm about the milestone in their partnership with QIAGEN. He highlighted the goal of extending the global reach of Myriad’s HRD-testing technology to drive broader clinical adoption. This collaboration showcases the unique capabilities of QIAGEN and Myriad in delivering proprietary content, advanced assay platforms, clinical trial execution, and worldwide CDx product distribution to pharmaceutical partners.

QIAGEN will oversee the development and distribution of the kit-based HRD test outside the United States. The intellectual property (IP) license enables QIAGEN to collaborate with pharmaceutical partners to create an IVD-validated test for use as a companion diagnostic outside the U.S. The combined regulatory expertise of QIAGEN and Myriad ensures seamless compliance and integration in clinical and companion diagnostic applications.

QIAGEN’s QIAseq panels are designed for efficient and accurate NGS library preparation, with over 4 million samples processed for cancer testing applications. QIAGEN has master collaboration agreements with more than 30 global pharma and biotech companies, facilitating advancements in precision medicine across various disease indications. Myriad has supported hundreds of clinical trials and obtained 10 companion diagnostic approvals from the FDA and PMDA, anticipating that the QIAGEN partnership will further expand Myriad’s oncology products portfolio.

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to improving health through genetic insights. QIAGEN N.V., based in the Netherlands, provides Sample to Insight solutions that enable valuable molecular insights from biological samples, serving customers in molecular diagnostics and life sciences worldwide.

This collaboration marks a significant step towards enhancing cancer diagnostics and personalized treatment, promising to make HRD tests more accessible to patients globally and support the development of companion diagnostics in collaboration with pharmaceutical partners.

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