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Qiagen, Myriad Genetics to Develop Sequencing-Based Homologous Recombination Deficiency Kit

NEW YORK – Qiagen and Myriad Genetics announced on Thursday that they have agreed to develop a globally distributable kit-based test for analyzing homologous recombination deficiency (HRD) status.

The agreement is an extension of a master collaboration the two companies announced in October.

Under the terms of the agreement, Qiagen will manage the development and distribution of HRD test kits outside the US. Qiagen has been granted the rights to collaborate with pharmaceutical partners to create an in vitro diagnostic-validated test, the firms said in a statement, which will be intended for use as a companion diagnostic outside of the US.

The next-generation sequencing-based HRD kits will combine Qiagen's QiaSeq xHYB technology and its Qiagen Digital Insight (QDI) informatics solution with Myriad's MyChoice CDx biomarkers.

The kits will support research and companion diagnostics development in collaboration with pharmaceutical partners, the firms said, adding that this potentially enables greater adoption and clinical indication expansion for MyChoice CDx. The combined regulatory expertise of Qiagen and Myriad will also enable seamless compliance and integration in clinical and companion diagnostic applications, the firms said.

Myriad’s MyChoice CDx is a single-site centralized testing service that assesses HRD status by examining a tumor's DNA repair capabilities, focusing on BRCA1 and BRCA2 gene mutations and calculating a genome instability score. The GIS aids in pinpointing ovarian cancer patients who are most likely to benefit from targeted treatments, the firms said.

"By introducing a distributable HRD test, we anticipate a reduction in the time required for therapy decisions, a decrease in associated costs, and shorter turnaround times compared to outsourced testing, ultimately benefiting the patients," said Fernando Beils, senior VP and head of Qiagen's molecular diagnostics business area.

The MyChoice CDx assay can identify 34 percent more tumors with HRD using the GIS score compared to other methods only using percent loss of heterozygosity, the firms noted. Approximately 48 percent of ovarian cancer tumors exhibit HRD, often due to specific mutations within the tumor, so expanding access to this assay is vital for advancing personalized medicine and ensuring that patients receive the most appropriate treatments, the firms added.

Myriad has also formed a similar agreement with Illumina, and other firms and academic groups are also developing and commercializing HRD assays.

Qiagen, meanwhile, has formed master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global pharma and biotech companies, the firms said.