EXENT® System now available in Australia and New Zealand

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 our 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. 

EXENT regional availability

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. 

Clinical benefits

• Enhanced Analytical Sensitivity: By pushing the boundaries of sensitivity, the EXENT System detects M-protein at diagnosis in patients that would not be detected by electrophoretic methods.^1,2

• Superior Disease Monitoring: Clinicians can monitor patients’ disease below the sensitivities of conventional methods, potentially removing the need for invasive bone marrow assessments.^3,4 

• More Informed Treatment Selection: Specifically track a patient’s disease and differentiate it from oligoclonal banding and known therapeutic antibody interference to improve the assignment of treatment response.^5-8

• Proactive Clinical Approach: Clinical users can detect biochemical relapse and help identify patients at risk of early progression.⁹

• Deeper Insights: The EXENT System identifies clinically relevant information such as post translational modifications and secondary clones.¹⁰

To learn more about the EXENT System, please click here.