Pharma Focus Asia

QIAGEN and Myriad Genetics Team Up to Create Global HRD Test for Research and Companion Diagnostics

Friday, May 31, 2024

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) have announced a partnership to create a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support personalized medicine research across multiple solid tumors, including ovarian cancer. The initiative builds on a recently established master collaboration agreement between the two companies, with an expectation to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners.

The HRD test will integrate QIAGEN’s QIAseq xHYB technology and Digital Insight solutions, creating a comprehensive sample-to-insight HRD solution, with Myriad’s FDA-approved MyChoice CDx. MyChoice CDx is a centralized testing service that assesses HRD in certain tumors by examining DNA repair capabilities, specifically focusing on BRCA1 and BRCA2 gene mutations, and calculating a Genome Instability Score (GIS). The GIS helps identify ovarian cancer patients who are likely to benefit from targeted treatments, such as LYNPARZA® (olaparib) by AstraZeneca.

“Our collaboration with Myriad Genetics demonstrates our shared commitment to advancing cancer diagnostics. By expanding access to HRD tests, we aim to help more cancer patients receive personalized treatments,” said Fernando Beils, Senior Vice President and Head of the Molecular Diagnostics Business Area at QIAGEN. “Introducing a distributable HRD test is expected to reduce the time needed for therapy decisions, decrease associated costs, and shorten turnaround times compared to outsourced testing, ultimately benefiting patients.”

The MyChoice CDx assay has shown the ability to identify 34% more tumors with HRD using the GIS score compared to methods that only use percent loss of heterozygosity (%LOH). Given that 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 that patients receive the most appropriate treatments.

“We’re excited to share this milestone in our partnership with QIAGEN as we work together to advance cancer care worldwide,” said Patrick Burke, Executive Vice President of Strategy and Innovation at Myriad Genetics. “By extending the global reach and accessibility of Myriad’s gold-standard HRD-testing technology, we aim to drive broader clinical adoption of HRD testing. This milestone showcases the unique capabilities of the QIAGEN and Myriad partnership to deliver proprietary content, cutting-edge assay platforms, clinical trial execution, and global CDx product distribution to our pharmaceutical partners.”

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

QIAGEN’s QIAseq panels facilitate 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, fostering precision medicine advancements across diverse disease indications by tailoring treatments to the genetic profiles identified by companion diagnostics testing. Myriad has supported hundreds of clinical trials, obtained 10 companion diagnostic approvals from the FDA and PMDA, and anticipates that its partnership with QIAGEN will expand Myriad’s oncology product portfolio.

Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of disease development or progression and guide treatment decisions across various medical specialties where genetic insights can significantly improve patient care and reduce healthcare costs.



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