Multiplicom NV has announced that it has achieved ISO 13485 accreditation, and is launching two new CE/IVD labeled DNA mutation detection kits for Cystic Fibrosis (CF) and Familial Mediterranean Fever (FMF), genetics diseases with a high carrier rate.
Dr Dirk Pollet, CEO of Multiplicom, said: “Having ISO 13485 accreditation establishes Multiplicom as a reliable supplier of diagnostic kits to clinical labs as well as to the major diagnostic companies worldwide. All Multiplicom MASTR products have a uniform protocol, require only standard equipment and are compatible with MPS equipment from Roche, Illumina and Thermo Fisher. The introduction of the new kits establishes Multiplicom as a European leader in the implementation of MPS in the routine clinical labs, enabling personalized medicine.”
Multiplicom was recently awarded ISO 13485:2003 and ISO 13485:2012 certification for “Design, development, manufacturing and distribution of in vitro molecular diagnostic test kits used for the identification of genomic and somatic variants.”
This week, at the European Society for Human Genetics in Milan, Multiplicom has announced the launch of two new CE/IVD labeled MASTR kits, for the comprehensive detection of mutations associated with CF in June and FMF in July. With these new CE/IVD labeled kits Multiplicom aims to take a significant market share in the screening markets for both diseases.
Multiplicom is operating in an area of rapid growth. The European MPS diagnostic market is expected to grow from €20M in 2012 to >€2,000M in 2018 (CAGR% >100%) within a worldwide market of >€6,000M in 2018.
Based on its success in Europe, with expected sales in 2014 of > €6M (CAGR%>100%), the ISO 13485 accreditation and the launch of new products for both genomic and somatic mutations, Multiplicom is now in pole position for additional growth in other major territories.