Thermo Fisher Scientific, a global leader in scientific services, announced the commercial launch of its EXENT solution after receiving IVDR certification*. The EXENT solution is a fully integrated, automated mass spectrometry system designed to transform the diagnosis and evaluation of patients with monoclonal gammaglobulinemia, including multiple myeloma. According to the World Health Organization in 2020, multiple myeloma becomes the second most prevalent blood cancer in the world^® [1]。 EXCEED SOLUTIONS ARE CURRENTLY AVAILABLE IN BELGIUM, FRANCE, GERMANY, ITALY, THE NETHERLANDS, SPAIN AND THE UNITED KINGDOM.

The EXENT solution enables clinical laboratories to measure, quantify, and track specific endogenous M proteins and exogenous therapeutic monoclonal antibodies with increased analytical sensitivity and specificity in serum. The EXENT solution is easy to deploy into everyday use in the laboratory and has three integrated modules. These modules are the EXENT-iP3 automated sample preparation system, the EXENT-iX500 matrix-assisted laser desorption-ionization time-of-flight mass spectrometer (MALDI-ToF MS), and the EXENT-iQ intelligent and intuitive workflow software including data review. The analyzer is combined with the EXENT immunoglobulin isotype (GAM) immunoassay, a sensitive and detailed immunoassay for the measurement and quantification of IgG, IgA, and IgM. ^®®®®

"The EXENT solution represents a breakthrough in innovation in monoclonal immunoglobulin detection and monitoring," said Stephen Harding, Ph.D., Chief Scientific Officer of Thermo Fisher's Protein Diagnostics.

Treatment of monoclonal gammaglobulinemia is usually determined by monitoring the level of M protein, which can indicate tumor size. Recent treatment outcomes have been impressive, with many patients achieving M protein concentrations below the detection limit using standard techniques. However, differences in the progression of the disease persist within this group. EXENT solutions address unmet clinical needs that require more sensitive analytical methods that can differentiate subsets. It even allows invasive bone marrow biopsy technology without starting early.

The EXENT solution was developed leveraging the intellectual property of the Mayo Clinic and combines industry leadership in innovation with Mayo's expertise in monoclonal gammaglobulinemia research. The EXENT solution is intended to assist in the diagnosis of monoclonal gammaglobulinemia and the monitoring of patients with multiple myeloma and Waldenstrom's macroglobulinemia.

Key features and innovations from EXENT solutions include:

• Increased analytical sensitivity: By pushing the boundaries of sensitivity, clinicians and laboratories can monitor patients to deeper levels of response using serum samples alone.
• Dynamic monitoring of unique M proteins: Track specific M proteins over time and enable identification of additional M proteins produced by emerging clones.
• Advanced visualization:View M proteins in a visually intuitive way to help clinicians and laboratories make informed decisions about endogenous M proteins.
• Simplified and less invasive serology testing: Prioritizes patient comfort and convenience by requiring simple, minimally invasive serology testing.
• Smart software with automated algorithmic data processing: Improve data accuracy and accelerate analysis with intelligent software support with automated algorithmic data processing that minimizes manual work.
• Quantification with Optilite analyzer:^®In combination with the Optilite analyzer, it enables accurate quantitation of M proteins for comprehensive and accurate results.

Earlier this year, Thermo Fisher Scientific completed the acquisition of The Binding Site, adding protein diagnostic solutions, including diagnostic and monitoring capabilities for monoclonal gammaglobulinemia, to its specialty diagnostic portfolio.