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Ovarian cancer CDx gains CE-IVD certification
April 2016
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NIEL, Belgium—Multiplicom N.V. has announced that its BRCA Tumor MASTR Plus Dx has received CE-IVD certification, making it Europe’s first CE-IVD companion diagnostic for identifying ovarian cancer patients with BRCA1 and/or BRCA2 mutations—based on the analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue—who may be candidates for treatment with PARP inhibitors. Ovarian cancer is the fifth most lethal cancer in Europe, with high-grade serous ovarian cancer, the most common type in this subset, associated with BRCA1 or BRCA2 mutations in 30 percent of patients.
 
“Treatment options are limited, but the combination of a targeted therapy with a companion diagnostic provides clinicians and patients with new options. There is a crucial need to know who is likely to respond favorably to a treatment before starting it,” said Dirk Pollet, CEO of Multiplicom. “Our BRCA Tumor MASTR Plus Dx allows local laboratories to identify patients who will benefit from a specific treatment.”\
 
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