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Multiplicom Receives CE-IVD Mark for Ovarian Cancer CDx Test

NEW YORK (GenomeWeb) – Molecular diagnostic firm Multiplicom of Belgium has received the CE-IVD mark for its BRCA Tumor MASTR Plus Dx test, the first ovarian cancer companion diagnostic test to receive this designation in Europe, the company said today.

The BRCA Tumor MASTR Plus Dx assay identifies somatic mutations in the coding regions of the BRCA1 and BRCA2 genes in formalin-fixed paraffin-embedded tumor tissue from ovarian cancer patients. The presence of such mutations indicates that the tumor may respond to PARP inhibitors, and the test results can be used as a diagnostic criterion for treatment with PARP inhibitors.

In 2012, Multiplicom was the first European company to obtain the CE-IVD mark for a BRCA test for breast and ovarian cancer predisposition. Last year, the company received the CE-IVD mark for its Clarigo noninvasive prenatal test for chromosomal aneuploidies, and earlier this year, it launched BRCA Tumor MASTR Plus Dx as a CE-IVD-labeled test for FFPE tumor samples.

The company's tests combine proprietary multiplex PCR technology with next-generation sequencing.