Illumina and Myriad Genetics Expand Strategic Collaboration to Enhance HRD Testing Accessibility in the U.S.

The strategic partnership between the two parties will provide a unique combination of diagnostic development and commercialization capabilities for the pharmaceutical industry.

San Diego, California, USAMarch 6, 2023/PR Newswire/ --March 2, 2023Illumina (NASDAQ: ILMN), the global leader in genomics and chip technology, and Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, have announced a further deepening of their strategic partnership. The two parties will work together to expand the accessibility and application of Homologous Recombination Deficiency (HRD) testing in oncology within the U.S. market. According to the cooperation agreement, Illumina's TruSight™ Oncology 500 HRD (TSO 500 HRD), a research-use-only testing product, is now available in the United States. The expansion of this partnership will also establish a unique Companion Diagnostics (CDx) alliance within the pharmaceutical industry to further advance clinical research on gene-based targeted therapies.

ExpandHRDAccessibility of Scientific Research Testing

TSO 500 HRD Research Assay Integrates Myriad’s Gold Standard Product, MyChoice^®CDx HRD Technology and Illumina's Pan-Cancer Detection TSO 500. This test was co-developed with Merck & Co., Inc. (known as MSD outside the United States and Canada) and Myriad Genetics. Following the initial collaboration with Myriad, Illumina...June 2022Launched the HRD and TSO 500 combination product globally (excluding the U.S. and Japanese markets).

TSO 500 HRD offers an independent, comprehensive pan-cancer detection solution, identifying key genetic alterations and homologous recombination repair deficiencies, which are crucial for understanding cancer development and progression. HRD status has become a significant biomarker for tumors with high levels of DNA damage, including ovarian, breast, prostate, and pancreatic cancers.

Kevin Keegan, Global Vice President and General Manager of Illumina's Oncology Business Unit, stated: "Research continues to reveal an increasingly strong correlation between HRD status and various cancers. The launch of this test product will support U.S. laboratories in obtaining the most comprehensive tumor analysis from a single sample."

Myriad Genetics General Manager of Oncology Michael Lyons said, "Our collaboration with Illumina combines best-in-class HRD technology and next-generation sequencing to create a comprehensive testing solution that can advance clinical research, ultimately benefiting patients. The launch of TSO 500 HRD in the United States will further strengthen our ability to collaborate with leading pharmaceutical companies and academic institutions, expand the accessibility of clinical trials, and accelerate the pace of research and scientific innovation."

The product is now available for order and shipping in the U.S. market. Illumina and Myriad will be responsible for providing the commercially available kit and centralized laboratory services, respectively. TSO 500 customers are looking forward to using the kit soon, including one of the largest independent oncology/hematology medical institutions in the U.S., Florida Cancer Specialists & Research Institute.

Lucio N. Gordan, MD, President and Managing Physician of Florida Cancer Specialists & Research Institute, said: "We are thrilled to offer Illumina’s TSO 500 genomic profiling pan-cancer assay and HRD evaluation within a single workflow. By utilizing Myriad Genetics’ MyChoice CDx technology, our physicians' preferred HRD testing method, this will enable a more comprehensive understanding of tumor genomics while maintaining laboratory efficiency. We look forward to expanding and deepening our collaboration with Illumina and Myriad Genetics."

Brand NewCDxAlliance 

Based on this strategic alliance, Illumina and Myriad Genetics hope to establish a joint HRD companion diagnostic partnership with pharmaceutical companies worldwide (excluding the Japanese market). The goal of the HRD CDx Consortium is to drive regulatory approval for MyChoice HRD companion diagnostics and future clinical in vitro diagnostic tests based on the TSO 500 HRD test.

Kevin Keegan, Global Vice President and General Manager of Illumina's Oncology Business Unit, stated: "This CDx Alliance aims to further promote global clinical research on HRD testing and treatment. It will help advance more clinical trials for precision gene therapies."