Revolutionizing diagnosis and assessment for patients with gammopathies
The EXENT System integrates immunoassay, MALDI-ToF mass spectrometry and intuitive data review software to provide enhanced analytical sensitivity and specificity for the measurement of monoclonal proteins
4 Nov 2024
The EXENT® System is an automated solution that enables M-protein identification and measurement.
Building on the clinical validation and IVDR Certification of the EXENT® System, Binding Site, part of Thermo Fisher Scientific, has now received regulatory authorization for the clinical use of the solution in Australia.
The EXENT® System is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies, enabling M-protein identification and measurement in serum with enhanced sensitivity beyond conventional methods.
Using a simple serum test, the EXENT System empowers clinicians to effectively diagnose and monitor patients with monoclonal gammopathies, including multiple myeloma, throughout their treatment journey with enhanced analytical sensitivity and specificity. The measurement of a patient’s M-protein over time helps inform whether a patient is responding to treatment, has stable disease, or may be relapsing.
According to the International Myeloma Foundation, over 176,000 new cases of multiple myeloma are reported globally each year. With treatment advancements in recent years, many patients are achieving M-protein concentrations below detectable limits using conventional techniques. However, differences in disease progression persist within this group, implying that current blood-based technologies fail to identify residual disease that may account for the difference in patient outcomes.
The EXENT System addresses this unmet clinical need for more sensitive blood-based analytical methods that can help differentiate between patient subsets. The ability to measure low levels of M-proteins undetected by conventional blood-based technologies can help inform the timing of a bone marrow biopsy to look for residual disease.
With the latest regulatory authorization and clinical validation, the EXENT System is now available for clinical use in Belgium, France, Germany, Italy, the Netherlands, New Zealand, Spain, United Kingdom, Switzerland and Australia.
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