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Multiplicom launches complete CE-IVD solution for all BRCA testing needs

The updated BRCA MASTR Plus Dx in combination with the new MASTR Reporter is a CE-IVD-labeled molecular diagnostic solution that identifies variants in the coding regions of BRCA1 and BRCA2 genes.

Belgium, 2 May 2017 – Multiplicom, now part of Agilent Technologies, announced today the extended CE-IVD certification of its BRCA MASTR Plus Dx. This next-generation molecular diagnostic solution uniquely detects both germline* (inherited) and somatic (acquired) mutations in BRCA1 and BRCA2 genes. In combination with the MASTR Reporter, both an analysis software and a quality control tool, it is the one solution for all BRCA mutation testing needs.

BRCA MASTR Plus Dx in combination with the MASTR Reporter is a CE-IVD-labeled molecular diagnostic solution (NGS library preparation kit, analysis software and quality control) that is used to identify mutations in the coding regions of the BRCA1 and BRCA2 genes. The assay can be applied to tumor and germline* samples from individuals with increased risk for breast, ovarian and/or related cancers. Simultaneous with the extension of the CE-IVD claim and the introduction of the MASTR Reporter, Multiplicom also launches the CE-IVD labeled drMID Dx for Illumina NGS systems. This solution is thus compatible with multiple market leading sequencers, including MiSeq®, MiniSeq® and NextSeq®.

Germline* mutations in BRCA1 and BRCA2 have been linked to the development of hereditary breast and ovarian cancer. In tumors, mutations in BRCA1 and BRCA2 have prognostic value and also predict the response to molecular targeted therapy, including PARP inhibitors (PARPi). Given the effectiveness of targeted therapy, screening for mutations in the BRCA genes in tumor samples becomes important. BRCA MASTR Plus Dx is compatible with DNA isolated from FFPE tumor samples and can be performed on low-input DNA from small tumor samples.

Breast cancer is a leading cause of significant morbidity and mortality for women. Despite its low prevalence, ovarian cancer is the 5th most lethal tumor type in Europe. High-grade serous ovarian cancer is the most common ovarian cancer and associated with BRCA1 or BRCA2 mutations in 30 % of patients. Understanding the molecular basis of these cancers, both germline* and somatic mutations, may inform treatment decisions. The availability of BRCA MASTR Plus Dx marks important progress towards a comprehensive molecular diagnostic solution for all BRCA mutations to enable personalized medicine in oncology.

Multiplicom has been a strong and reliable player in molecular diagnostics for many years. The company provides clinical laboratories with a broad range of molecular diagnostics NGS solutions. As of today all new diagnostic kits, the BRCA Hereditary Cancer MASTR and the BRCA MASTR Dx will include a robust software tool, the MASTR Reporter that ensures better data analysis and quality control enabling clinical laboratories to guarantee innovative molecular tests of the highest quality.

* Currently, only germline analysis is enabled on the MASTR Reporter