CE-IVD marking of the Coagulation ELITe MGB® Kit

Puteaux, France, 27th January 2017 - ELITechGroup Molecular Diagnostics announced today the CE-IVD marking of the Coagulation ELITe MGB® Kit, a high-performance, multiplex assay for the detection of genetic variants associated with higher risk of deep venous thrombosis. Deep venous thrombosis is a multifactorial disease and major health problem which can annually affect 1 in 1000 persons.

Coagulation ELITe MGB® Kit is intended to detect and differentiate the most common genetic risk variants responsible for thrombosis and embolisms: coagulation Factor V variant G1691A (Leiden); coagulation Factor II variant G20210A, and MTHFR variant C677T. The detection of these single nucleotide polymorphisms is especially required in individuals with personal or familial history of recurrent thrombosis. In combination with the ELITe InGenius® system, the Coagulation ELITe MGB® Kit is the first coagulation factors triplex, CE-IVD validated on a fully automated sample-to-result solution. The Coagulation ELITe MGB® Kit is a monoreagent, ready-to-use, real-time PCR assay, based on the proprietary industry-leading Minor Groove Binder (MGB) Technology. Excellent clinical performance was demonstrated: 100% specificity for each variants and 98.5%, 100%, 100% sensitivity respectively for Factor V, Factor II and MTHFR.

“The Coagulation ELITe MGB® Kit is an advanced molecular assay to better and faster identify patients at risk for thrombosis. In combination with ELITe InGenius, it provides a high-performance, and fully automated solution for a better patient management. Patient samples can be directly loaded in the system, which automatically performs all the steps of molecular diagnostics from extraction to results interpretation with a minimal hands-on time and limiting the risk of errors” commented Christoph Gauer, CEO of ELITechGroup

Additionally, this new assay is the first genetic testing assay CE-IVD validated on the system, and marks the menu expansion toward new clinical applications. ELITe InGenius has so far been focused on infectious disease conditions offering a unique comprehensive menu for transplant pathogen monitoring, and healthcare associated infections.

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