Illumina and Myriad Genetics Expand Partnership to Broaden Access to HRD Testing in the United States

Illumina, a global leader in DNA sequencing and array-based technologies, and Myriad Genetics, a leader in genetic testing and precision medicine, have announced the expansion of a strategic partnership to broaden access to and availability of oncology homologous recombination deficiency (HRD) testing in the United States. Under the agreement, Illumina TruSight™ Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US. The expanded partnership also establishes a unique companion diagnostic (CDx) alliance for the pharmaceutical industry, which will enable more clinical research for gene-based, targeted therapies.

The TSO 500 HRD research test aligns Myriad’s gold standard MyChoice® CDx HRD technology with Illumina’s pan-cancer test, TSO 500. The test was codeveloped with Merck (known as MSD outside the US and Canada) and Myriad Genetics. Myriad and Illumina’s initial partnership led to Illumina’s combined HRD and TSO 500 offering launch worldwide—excluding the US and Japan—in June 2022. TSO 500 HRD offers a single, comprehensive pan-cancer test to identify key genetic variants and homologous recombination deficiency critical for understanding cancer development and progression. HRD status is an important biomarker in tumors that harbor high levels of DNA damage, such as those present in ovarian, breast, prostate, and pancreatic cancers.

“Research continues to reveal the growing relevance of HRD status across multiple cancers,” said Kevin Keegan, vice president and general manager of, Oncology Business Unit, at Illumina. “Now with this test, we are empowering labs in the US to unlock the most comprehensive tumor analysis from a single sample.”

“Our partnership with Illumina brings together best-in-class HRD technology and next-generation sequencing to create a comprehensive testing solution that supports the advancement of clinical research which should ultimately lead to an improvement for patients,” said Michael Lyons, general manager of Oncology, Myriad Genetics. “The availability of TSO 500 HRD in the US furthers our ability to partner with leading pharmaceutical companies and academic institutions, broadens access to clinical trials, and accelerates the pace of research and scientific innovation.”

The product is available to order now and ready to ship in the US. Illumina and Myriad are offering distributable kits and centralized laboratory service, respectively. TSO 500 customers, such as Florida Cancer Specialists & Research Institute, one of the largest independent medical oncology/hematology practices in the US, are anticipating access to the kit.

“We are excited for the opportunity to provide Illumina’s TSO 500 genomic profiling pan-cancer test with HRD assessment in a single workflow,” said Dr. Lucio N. Gordan, president and managing physician at Florida Cancer Specialists & Research Institute. “Leveraging technology from Myriad’s MyChoice CDx, our physician’s first choice among HRD tests, will help to unlock comprehensive understanding of the tumor genome and maintain laboratory efficiency. We look forward to expanding and building upon our relationships with both Illumina and Myriad Genetics.”