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Multiplicom, a molecular diagnostics company specializing in innovative molecular genetics tests based on massive parallel sequencing, has received CE/IVD mark accreditation for its first-in-class BRCA MASTR Dx test. The test identifies mutations in the coding regions of the BRCA 1&2 genes in individuals with increased risk for breast, ovarian and/or related cancers.
The test will significantly reduce the amount of validation that genetic laboratories need to perform prior to using the test in clinical routine. BRCA MASTR Dx allows high throughput and cost effective sequencing for diagnostic purposes and will be shipped throughout Europe from September 2012.
BRCA MASTR Dx is the latest version of the current BRCA MASTR v2 kit which meets all the requirements of its class of in vitro diagnostic kits under EU regulations.
“The CE marking of the BRCA MASTR Dx test contributes significantly in achieving accreditation in our lab” said Dr. Pascale Hilbert, Head of Molecular Genetics at Institut de Pathologie et de Génétique, Gosselies in Belgium.
Dr. Dirk Pollet, CEO of Multiplicom, said “Over the past 12 months we have heavily invested in setting up a quality system that meets the European CE/IVD requirements. This has been a major effort that has made this first-in-class product possible, and at the same time it has facilitated the development of other CE/IVD products”.
Luc Segers, VP Marketing and Sales of Multiplicom added, “Thanks to our recently established European wide sales network, we will be able to introduce the CE/IVD labelled products very efficiently throughout the European market and provide high quality customer support.”
Validation studies of the BRCA MASTR Dx were performed in several genetic centres in France and Belgium in combination with 454 sequencing instruments of Roche (GS Junior & GS FLX). The results of these studies will be presented at Multiplicom’s satellite symposium preceding the European Human Genetics Conference (ESHG) in Nurnberg, Germany (23-26 June 2012) on June 23rd, at 2pm CET.
Multiplicom will also be showcasing its BRCA MASTR Dx during ESHG at its stand (no. 226).
The BRCA MASTR Dx is a molecular diagnostic assay for the identification of mutations in the coding regions of the BRCA 1&2 genes in individuals with increased risk for breast, ovarian and/or related cancers compatible with Roche’s 454 sequencers.
Multiplicom’s MASTR (Multiplex Amplification of Specific Targets for Resequencing) assays are ready to use and offer robust performance with minimum hands-on time. All reagents necessary to enable multiplex amplification of 93 amplicons (289-430 bp) are included, for complete exon coverage of all coding sequences. The assays are compatible with all current Massive Parallel Sequencing (MPS) platforms, giving the flexibility to choose a preferred technology.
Multiplicom produces molecular diagnostic kits that enable clinical laboratories to perform affordable testing for personalized medicine. The Company was created in 2011 as a spin-off by the University of Antwerp and VIB. Multiplicom develops, manufactures and commercializes leading-edge and easy-to-use genetic test kits based on the latest molecular diagnostic technologies. The successful introduction of its kits in medical genetics labs proves they are the solution to an increasing demand for nucleic acid based testing that is driven by the scientific evidence that links genetic information to health and disease.
Source: Multiplicom
Tags: regulatory, research
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