Multiplicom NV, a specialist in the development, production and commercialization of innovative molecular genetic tests based on massively parallel sequencing (MPS), 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 ThermoFisher. 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 announces 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.

Cystic Fibrosis is a life threatening, infancy onset, autosomal recessive disorder with an incidence of about 1 in 2,500 live births and a carrier frequency of about 1 in 25 in individuals from European descent. Today, the median predicted age of survival for a person with CF is between 34 and 47 years, but the median age of death remains in the mid--20s.

More than 1,965 variants in the CFTR gene have been identified, of which worldwide fewer than 20 mutations occur with a frequency above 0.1%. The mutations occur with regional or ethnic variation in frequency and give rise to a wide--range of clinical symptoms. CFTR variants are also found in CF--related phenotypes, such as CBAVD, present in 25% of patients with excretory azoospermia.

Familial Mediterranean fever is an, autosomal recessive, auto--inflammatory syndrome characterized by recurrent short episodes of high fever associated with abdominal pain, inflammation of joints and other body sites and skin rash. If untreated, amyloidosis commonly develops and may have a fatal outcome. Familial Mediterranean fever is the most common of the periodic fever syndromes and affects specific racial groups originating from around the eastern Mediterranean Sea. In these groups, 1 in 25 to 1 in 2000 people are affected. The carrier rate can be as high as 1 in 3 in some groups.

Familial Mediterranean fever is most often caused by in the MEFV gene located on chromosome 16 (16p13.3). Mutations in MEFV have been found in 80% of typical cases. More than 200 disease--causing mutations have been identified so far.

Multiplicom NV is a Belgian biotech company focused on human molecular diagnostics. The company produces molecular diagnostic kits that enable clinical laboratories to perform affordable testing for personalized medicine.