NEW YORK – Thermo Fisher Scientific said on Thursday that its Exent Solution, an automated mass spectrometry system for diagnosing patients with monoclonal gammopathies, including multiple myeloma, has been approved under Europe's In Vitro Diagnostics Regulation.
With the IVDR certification, Thermo Fisher said the Exent platform is now commercially available in Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK.
Containing three integrated modules for automated sample preparation, mass spectrometry, and data review, the Exent platform promises to enable clinical laboratories to measure, quantify, and track specific endogenous M-proteins and exogenous therapeutic monoclonal antibodies with enhanced analytical sensitivity and specificity in serum, Thermo Fisher said.
The analyzer is intended for use with the Exent Immunoglobulin Isotypes (GAM) immunoassay, which can measure and quantify IgG, IgA, and IgM.
According to Thermo Fisher, the Exent Solution, which adds to the company’s protein diagnostics portfolio with its Binding Site Group acquisition, was developed with Mayo Clinic intellectual property.