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Illumina, Merck Partner to Advance Homologous Recombination Deficiency CDx, Research Assay

NEW YORK – Illumina and Merck provided more details on Tuesday about their partnership to develop and commercialize tests that gauge genetic mutations involved in homologous recombination deficiency, or HRD, and identify best responders to PARP inhibitors.

Illumina first announced the partnership in January at the JP Morgan Healthcare Conference.

Under the terms of the agreement, Illumina will develop a new HRD companion diagnostic for the European Union and UK markets that will aid in the identification of ovarian cancer patients who are eligible for treatment with olaparib (Lynparza), a PARP inhibitor jointly developed and commercialized by Merck and AstraZeneca.

Illumina will also develop a research-use only HRD assay that will be add-on content for its TSO 500 panel. The company will launch the RUO assay globally, but not in the US or Japan. Financial details of the partnership were not disclosed.

The deal builds on Illumina's relationship with Myriad Genetics to expand international access to technology used in Myriad's US Food and Drug Administration-approved myChoice CDx test, which assesses three HRD pathways as well as BRCA1 and BRCA2 mutations and provides a genomic instability score. The test is approved in the US to identify best responders to two PARP inhibitors used to treat ovarian cancer, olaparib and niraparib (GlaxoSmithKline's Zejula).

In November 2020, Myriad announced plans to expand access to myChoice in Europe by licensing its technology to pathology institutes in Germany and France. The Utah-based molecular diagnostics firm also partnered with AstraZeneca in 2018 to use its myChoice HRD Plus assay in a clinical trial of olaparib and bevacizumab (Genentech's Avastin). The myChoice HRD Plus assay analyzes three HRD pathways, BRCA1/2 mutations, and alterations in an additional 102 genes.

Illumina launched its TSO 500 assay in 2018. It also has a collaboration with Bristol Myers Squibb to develop and commercialize companion diagnostics based on TSO 500.