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Illumina, Myriad Genetics Expand Partnership to Bring TSO 500 HRD Assay to US

NEW YORK – Illumina and Myriad Genetics said on Thursday that they have expanded their strategic partnership on homologous recombination deficiency (HRD) testing.

Under the terms of the agreement, Illumina's TruSight Oncology 500 HRD research-use-only assay will now be available in the US. Illumina will offer distributable kits while Myriad will offer a centralized laboratory service.

The firms have also created a companion diagnostic alliance for the pharmaceutical industry to help pursue regulatory approvals for both the MyChoice HRD assay companion diagnostic and a future clinical in vitro diagnostic test based on the TSO 500 HRD assay. Under this strategic alliance, Illumina and Myriad will seek joint HRD companion diagnostic partnerships with pharmaceutical companies worldwide, excluding Japan.

Financial and other terms of the deal were not disclosed.

"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," Michael Lyons, general manager of oncology at Myriad Genetics, said in a statement.

The TSO 500 HRD research test, codeveloped with Merck, combines Myriad's MyChoice CDx HRD technology with Illumina's TSO 500 pan-cancer sequencing panel. Initially, it was available only outside the US and Japan.

TSO 500 analyzes both DNA and RNA from tumor samples to identify key genetic variants associated with cancer development and progression, such as small DNA variants, fusions, and splice variants. The TSO 500 HRD assay additionally targets genetic mutations used in the evaluation of HRD, a genomic signature associated with an inability for a cell to repair double-stranded DNA breaks. HRD status can help recommend patients for therapy with PARP inhibitors.

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