By Diagnostics World Staff
March 8, 2023 | Illumina’s TruSight Oncology 500 HRD (TSO 500 HRD), a research-use-only oncology homologous recombination deficiency (HRD) test, is now available in the US thanks to an expanded partnership between Illumina and Myriad Genetics. 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.
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.
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. But now the product is available to order and ready to ship in the US. Illumina is offering distributable kits and Myriad is offering centralized laboratory service.
"Research continues to reveal the growing relevance of HRD status across multiple cancers," said Kevin Keegan, vice president and general manager, Oncology Business Unit, at Illumina in a press release. "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," added Michael Lyons, general manager of Oncology, Myriad Genetics in the same statement. "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 two companies also announced a strategic alliance for companion diagnostics. They plan to seek joint HRD companion diagnostics partnerships with pharmaceutical companies worldwide (excluding Japan). The joint HRD CDx alliance will aim to pursue HRD regulatory approvals for both the MyChoice HRD Assay companion diagnostic and a future clinical in vitro diagnostic test based off the TSO 500 HRD Assay.
"This CDx alliance aims to further enable clinical research for HRD testing and therapeutics, globally. Which could lead to greater access to clinical trials for precision, gene-based therapies," said Keegan.