Illumina (NSDQ:ILMN) and Merck today announced a partnership to develop diagnostics for identifying certain genetic mutations.
The partnership aims to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD), leveraging Illumina’s TruSight Oncology 500 (TSO 500) content, enabling what the companies tout as the most comprehensive genomic profiling assays in a single worfklow.
San Diego-based Illumina said in a news release that the partnership builds upon an initial study conducted between the two companies and uses Illumina’s relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad’s FDA-approved myChoice CDx companion diagnostic test.
Under the partnership, Illumina will develop a new HRD CDx test for the European Union and the UK to aid in the identification of ovarian cancer patients with positive HRD status who are eligible for treatment with LYNPARZA (olaparib), a first-in-class PARP inhibitor, jointly developed and commercialized by Merck and AstraZeneca.
Additionally, Illumina will develop and commercialize a research-use-only (RUO) HRD assay that will be add-on content for the TSO 500 RUO panel, with plans for a global product launch, excluding the U.S. and Japan.
“With such great advances in precision medicine being made by companies such as Merck, it’s essential that patients who would benefit from LYNPARZA are identified,” Illumina chief strategy and corporate development officer Joydeep Goswami said in the release. “By leveraging our comprehensive genomic profiling family of products, TruSight oncology, and the gold standard myChoice HRD technology, Illumina aims to offer the best-in-class HRD assay that is broadly accessible. By harnessing the incredible medicines development expertise of Merck, together we will be able to leverage the use of precision medicines to make a real difference for patients.”
“HRD testing should be an essential component of clinical diagnosis as half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors,” added Merck SVP of early-stage development, clinical oncology Dr. Eric H. Rubin. “Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target a devastating disease, like ovarian cancer and we are excited to partner with Illumina on the development of a distributed CDx HRD assay for the EU and UK.”