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Jun 19, 2012

Multiplicom Achieves CE Mark for BRCA1&2 Gene Mutation In Vitro Diagnostic

  • Molecular diagnostics firm Multiplicom received CE/IVD mark accreditation for its BRCA MASTR Dx test, which is designed to identify coding region mutations in the BRCA1 and BRCA2 genes in patients with increased risk of breast, ovarian and related cancers. The assay is the latest version of the firm’s BRCA MASTR v2 kit. The CE mark was granted on the basis of validation studies in combination with 454 sequencing instrumentation.

    Belgium-based Multiplicom was spun out of the University of Antwerp and VIB in 2011 to develop and commercialize molecular genetic tests based on massive parallel sequencing. Earlier this month the firm was awarded a €200,000 ($260,000) grant from the Flemish agency for Innovation by Science and Technology (IWT) to support the development of a maternal blood-based test for fetal genetic abnormalities. Based on the MASTR (multiplex amplification of specific targets for resequencing) workflow, the assay is designed as a single tube multiplex PCR reaction that can detect copy number variations in fetal DNA present in the mother’s blood.

    In May the firm inked an agreement with ICM (Institut du Cerveau et de la Moelle epinière) and ICAN (Institute of Cardiométabolisme And Nutrition) to jointly develop molecular diagnostic tests to identify risk mutations for cardiovascular, metabolic, and neurological diseases. ICAN and ICM are two Hospital-University Institutes at Hôpital Pitié Salpêtrière in Paris, which are specialized in cardiovascular/metabolic and neurological diseases, respectively. Under terms of this deal the partners will aim to develop and validate diagnostic tests for the identification of disease-related mutations based on massive parallel sequencing.


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