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Multiplicom Garners Extended CE Mark for BRCA Testing Kit

NEW YORK (GenomeWeb) – Belgian molecular diagnostics firm Multiplicom said yesterday that it has received extended CE-IVD certification for its BRCA Mastr Plus Dx product.

The BRCA Mastr Plus Dx in combination with Mastr Reporter comprises a next-generation sequencing library preparation kit, analysis software, and quality control to identify mutations in the coding regions of the BRCA1 and BRCA2 genes. Previously, only the BRCA Mastr Plus Dx component had CE-IVD certification.

BRCA Mastr Plus Dx and Mastr Reporter can be applied to tumor and germline samples from individuals with increased risk for breast, ovarian, and/or related cancers, although the Mastr Reporter software is currently only capable of germline analysis, the company said. The Dx component is compatible with DNA isolated from FFPE tumor samples and can be performed on low-input DNA from small tumor samples, Multiplicom added.

Simultaneous with the new CE-IVD claim, Multiplicom said it has launched its CE-IVD-labeled drMID Dx for Illumina NGS systems.