The system is now available commercially in the UK, the Netherlands, Spain, Italy, Germany, France and Belgium.
EXENTSolution, which received in vitro diagnostic regulation (IVDR) certification, is intended to diagnose and evaluate patients with monoclonal gammopathies, including multiple myeloma.
Clinical laboratories can use the system for measuring, quantifying and tracking endogenous M-proteins and exogenous therapeutic monoclonal antibodies with improved analytical sensitivity and specificity in serum.
It features the EXENT-iP 500 automated sample preparation instrument, the EXENT-iX500 matrix-assisted laser desorption ionisation time of flight mass spectrometer and the EXENT-iQ intelligent and workflow software with data review.
To measure and quantify IgG, IgA, and IgM, the analyser is integrated with the EXENTimmunoglobulin isotypes immunoassay.
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Developed utilising intellectual property from Mayo Clinic, the solution has key features, including dynamic monitoring of unique M-proteins and better visualisation.
Other features include simplified and less invasive serum testing, smart software with automated algorithm data processing and quantification with the Optilite analyser.
Thermo Fisher Protein Diagnostics chief scientific officer Dr Stephen Harding said: “The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins.”
At the start of this year, the company concluded the acquisition of the Binding Site, adding protein diagnostics solutions that included diagnosis and monitoring for monoclonal gammopathies to its speciality diagnostics portfolio.