IVDR-Certified Mass Spectrometry Diagnostic System to Transform Detection of Monoclonal Gammopathies

Monoclonal gammopathies, including multiple myeloma, rank as the second most prevalent blood cancer globally, according to the 2020 report from the World Health Organization. Traditionally, treatment for these conditions involves monitoring M-protein levels, which can indicate the size of tumors. Despite significant treatment advancements, many patients are now achieving M-protein concentrations below detectable limits through standard methods. Yet, variations in disease progression persist within this patient group. Now, a new solution addresses this unmet clinical need for more sensitive analytical techniques that can differentiate between subsets of patients without resorting to invasive bone marrow biopsies prematurely.

Thermo Fisher Scientific (Waltham, MA, USA) has commercially launched the EXENT Solution after obtaining IVDR certification. This comprehensive and automated mass spectrometry system is designed to revolutionize diagnosis and assessment for individuals with monoclonal gammopathies. By utilizing the EXENT Solution, clinical laboratories can precisely measure, quantify, and monitor specific endogenous M-proteins and exogenous therapeutic monoclonal antibodies with heightened analytical sensitivity and precision in serum samples. The EXENT Solution has been developed to support the diagnosis of monoclonal gammopathies and facilitate the monitoring of patients with multiple myeloma and Waldenström's macroglobulinemia.

The EXENT Solution seamlessly integrates into routine laboratory workflows and comprises three integrated modules: EXENT-iP 500, an automated sample preparation instrument; EXENT-iX 500, a Matrix Assisted Laser Desorption Ionization - Time of Flight Mass Spectrometer (MALDI-ToF MS); and EXENT-iQ, an intelligent and user-friendly workflow software with data review capabilities. The system is complemented by the EXENT Immunoglobulin Isotypes (GAM) immunoassay, which is highly sensitive and specific for measuring and quantifying IgG, IgA, and IgM. The EXENT Solution is now available for commercial use in several countries, including Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.

“The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins,” said Dr. Stephen Harding, Chief Scientific Officer, Protein Diagnostics, Thermo Fisher.

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