eClinical Technology and Industy News

Illumina Partners with Merck to Develop and Commercialize Companion Diagnostic and Research Tests for Use in Identifying Specific Cancer Mutations

Excerpt from the Press Release:

SAN DIEGO, Sept. 7, 2021 /PRNewswire/ — Illumina, Inc. (NASDAQ: ILMN) and Merck (known as MSD outside the United States and Canada) today announced a partnership to develop and commercialize tests that 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 Illumina’s TruSight™ Oncology 500 (TSO 500) content, enabling the most comprehensive genomic profiling assays in a single workflow.

This strategic partnership builds on an initial study conducted with Merck and leverages Illumina’s relationship with Myriad Genetics (NASDAQ: MYGN) 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 United States and Japan.

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