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Illumina and Merck Partner to ID Cancer Mutations

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The partnership would allow for the development of companion diagnostics that will identify genetic mutations used in the assessment of homologous recombination deficiency (HRD).

Illumina and Merck are collaborating to develop companion diagnostics to identify cancer mutations.

The companion diagnostics will identify genetic mutations used in the assessment of homologous recombination deficiency (HRD).

Patients whose tumors are HRD-positive may be eligible for targeted treatment by a class of precision medicines called PARP inhibitors. The HRD tests will leverage San Diego, CA-based Illumina's TruSight Oncology 500 (TSO 500) content, enabling the most comprehensive genomic profiling assays in a single workflow.

The collaboration builds on an initial study conducted with Merck and leverages Illumina's relationship with Myriad Genetics to expand international access to the proprietary technology in Myriad's FDA approved myChoice  CDx companion diagnostic test. Illumina will develop a new HRD CDx test for the EU 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.

In addition, Illumina will develop and commercialize a research use only (RUO) HRD assay that will be add-on content for the TSO 500 RUO panel. Illumina plans to launch this product globally, 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," said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. "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."

Illumina’s collaboration with Merck comes shortly after the gene-sequencing specialist closing out its $8 billion acquisition of Grail – ahead of anti-trust investigations conducted by the Federal Trade Commission and the European Commission.

During an earnings call that occurred before Illumina closed out the acquisition, the company’s CEO said, “We continue to believe that this deal will result in the savings of tens of thousands of lives that would not be saved if we didn't buy Grail just simply because we can accelerate the business,” according to a transcript of from The Motley Fool.

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