Qiagen and Myriad Genetics have announced a significant development in their collaboration, aiming to create a globally distributable kit-based test for analyzing homologous recombination deficiency (HRD) status. This extension builds upon their prior master collaboration announced in October, wherein Qiagen will spearhead the development and distribution of HRD test kits outside the US. These kits are intended to serve as companion diagnostics, facilitating therapy decisions and improving patient outcomes.
The test kits will leverage Qiagen’s QiaSeq xHYB technology and Qiagen Digital Insight (QDI) informatics solution along with Myriad’s MyChoice CDx biomarkers. These next-generation sequencing-based kits will support research and companion diagnostics development in partnership with pharmaceutical collaborators. This collaboration aims to broaden the adoption and clinical indication expansion for MyChoice CDx, offering regulatory compliance and integration for clinical and companion diagnostic applications.
Myriad’s MyChoice CDx assay is a centralized testing service that evaluates HRD status by analyzing a tumor’s DNA repair capabilities, focusing on BRCA1 and BRCA2 gene mutations, and calculating a genome instability score (GIS). This assay aids in identifying ovarian cancer patients who may benefit from targeted treatments. The introduction of a distributable HRD test is expected to streamline therapy decisions, reduce costs, and shorten turnaround times compared to outsourced testing.
The MyChoice CDx assay, with its GIS score, can identify a significantly higher number of tumors with HRD compared to other methods, contributing to the advancement of personalized medicine. Approximately half of ovarian cancer tumors exhibit HRD, emphasizing the importance of expanding access to this assay for ensuring patients receive optimal treatments.
Aside from this collaboration, Myriad has similar agreements with Illumina, while Qiagen has established collaboration agreements with over 30 global pharmaceutical and biotech companies for companion diagnostics development and commercialization. These efforts collectively aim to enhance diagnostic capabilities, drive personalized medicine, and improve patient care outcomes on a global scale.