Thermo Fisher Scientific Introduces IVDR Certified EXENT® Solution Launch

Friday, August 25, 2023

Thermo Fisher Scientific, renowned for its leadership in scientific services, has officially introduced the EXENT® Solution to the market. This step follows the certification under the In Vitro Diagnostic Regulation (IVDR)*. The EXENT Solution is an advanced, fully automated mass spectrometry system aimed at revolutionizing the diagnosis and evaluation of patients with monoclonal gammopathies. These conditions include multiple myeloma, which stands as the second most prevalent blood cancer globally, as reported by the World Health Organization in 2020[1]. The commercial availability of the EXENT Solution has commenced in select European countries, including Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.

In essence, the EXENT Solution empowers clinical laboratories to precisely measure, quantify, and continually monitor specific endogenous M-proteins and therapeutic monoclonal antibodies in the serum. With its exceptional analytical sensitivity and specificity, the solution integrates three seamlessly interconnected modules: the EXENT-iP®500 for automated sample preparation, the EXENT-iX®500 which utilizes Matrix Assisted Laser Desorption Ionization - Time of Flight Mass Spectrometry (MALDI-ToF MS), and the EXENT-iQ®, an intelligent workflow software complete with data review capabilities. The system also incorporates the EXENT® Immunoglobulin Isotypes (GAM) immunoassay, a recognized method for accurately quantifying IgG, IgA, and IgM.

Dr. Stephen Harding, Chief Scientific Officer of Protein Diagnostics at Thermo Fisher, emphasized the transformative potential of the EXENT Solution, highlighting its significant contribution to the field of monoclonal immunoglobulin detection and monitoring.

Traditionally, the management of monoclonal gammopathies relies on monitoring M-protein levels, which provide insights into tumor size. While recent years have witnessed substantial treatment advancements that have enabled patients to achieve M-protein concentrations below detectable limits using conventional techniques, variations in disease progression remain among individuals. Addressing this challenge, the EXENT Solution aims to fulfill the clinical demand for highly sensitive analytical methods capable of distinguishing between subsets, thereby avoiding the need for early invasive bone marrow biopsies.

A result of collaboration with the Mayo Clinic's intellectual property, the EXENT Solution combines industry innovation with Mayo's expertise in monoclonal gammopathy research. Its primary purpose lies in facilitating the diagnosis of monoclonal gammopathies and the monitoring of patients with conditions such as multiple myeloma and Waldenström's macroglobulinemia.

The EXENT Solution is distinguished by a range of innovative features:

1. Enhanced Analytical Sensitivity: Pushing the boundaries of sensitivity, allowing clinicians and laboratories to achieve more comprehensive response monitoring using just a serum sample.

2. Dynamic Monitoring of Specific M-proteins: Facilitating ongoing tracking of particular M-proteins, enabling the detection of additional M-proteins produced by emerging clones.

3. Advanced Visualization: Presenting M-proteins in a user-friendly visual format, aiding clinicians and laboratories in making informed decisions concerning endogenous M-proteins.

4. Simplified and Less Invasive Serum Testing: Prioritizing patient comfort and convenience by requiring a simple and minimally invasive serum test.

5. Intelligent Software with Automated Algorithmic Data Processing: Supported by intelligent software equipped with automated algorithmic data processing, minimizing manual efforts, improving data accuracy, and expediting analysis.

6. Quantification with the Optilite® Analyzer: In conjunction with the Optilite Analyzer, ensuring precise quantification of M-proteins for comprehensive and accurate outcomes.

Earlier this year, Thermo Fisher Scientific completed the acquisition of The Binding Site, thus integrating protein diagnostics solutions – including diagnosis and monitoring for monoclonal gammopathies – into its portfolio of specialty diagnostics.


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