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September 8, 2021

Illumina and Merck to develop tests for detection of cancer mutation

The HRD CDx test will aid in identifying HRD-positive ovarian cancer patients eligible for treatment with Lynparza. 

Illumina has entered a collaboration with Merck (MSD) to develop and market companion diagnostic (CDx) and research tests that would be used in identifying specific cancer mutations.

The companies will develop tests that detect genetic mutations used in the homologous recombination deficiency (HRD) analysis.

These CDx tests will be used to identify HRD-positive tumour patients who are eligible for targeted therapy using a class of precision treatments called poly adenosine diphosphate-ribose polymerase (PARP) inhibitors.

The HRD tests will utilise the TruSight Oncology 500 (TSO 500) content of Illumina, providing the most comprehensive genomic profiling assays in one workflow.

Illumina will create a novel HRD CDx test for the European Union and UK region to facilitate the detection of HRD-positive ovarian cancer patients who are eligible for Lynparza (Olaparib) treatment.

Lynparza is a first-in-class PARP inhibitor, which was co-developed and co-marketed by Merck and AstraZeneca.

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Furthermore, Illumina will create and market a research use only HRD assay that will be offered as add-on content for the TSO 500 RUO panel.

It also intends to introduce the assay across the globe, excluding the US and Japanese markets.

The latest strategic collaboration builds on an initial study carried out with Merck and leveraging Illumina’s partnership with Myriad Genetics to expand global access to the technology in Myriad’s myChoice CDx test.

The myChoice CDx test is approved by the US Food and Drug Administration (FDA).

Illumina chief strategy and corporate development officer Joydeep Goswami said: “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.

“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.”

Last month, Illumina completed the acquisition of Grail for a cash and stock consideration of $8bn to accelerate patient access to the latter’s multi-cancer early-detection test.

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