Illumina launched its TSO 500 assay in 2018. The m圜hoice HRD Plus assay analyzes three HRD pathways, BRCA1/2 mutations, and alterations in an additional 102 genes.
#Hrd genes trial
The Utah-based molecular diagnostics firm also partnered with AstraZeneca in 2018 to use its m圜hoice HRD Plus assay in a clinical trial of olaparib and bevacizumab (Genentech's Avastin). In November 2020, Myriad announced plans to expand access to m圜hoice in Europe by licensing its technology to pathology institutes in Germany and France. 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). 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 m圜hoice CDx test, which assesses three HRD pathways as well as BRCA1 and BRCA2 mutations and provides a genomic instability score. Financial details of the partnership were not disclosed. The company will launch the RUO assay globally, but not in the US or Japan. Illumina will also develop a research-use only HRD assay that will be add-on content for its TSO 500 panel. 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 first announced the partnership in January at the JP Morgan Healthcare Conference.
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.