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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.
EXENT, EXENT-iP500, EXENT-iX500, EXENT-iQ, and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries.
*The EXENT System consists of the following CE marked products:
EXENT Analyser, IE800 (IVDR Class A, non-sterile).
Immunoglobulin isotypes (GAM) for the EXENT Analyser - MSR801.M (IVDR Class C)
EXENT Immunoglobulin Isotypes (GAM) Control Pack - MSQ801.M (IVDR Class C).
**The EXENT System combines EXENT Analyser with the Immunoglobulin Isotypes (GAM) for the EXENT Analyser
***EXENT Analyser (ARTG no. 454106); EXENT Immunoglobulin Isotypes (GAM) for EXENT Analyser (ARTG no. 460347).
References
1. Giles HV, et al. Redefining nonmeasurable multiple myeloma using mass spectrometry. Blood 2022; 139:946-95
2. Immunoglobulin Isotypes (GAM) for the EXENT Analyser Instructions for Use
3. Puig N, et al. Clinical Impact of next generation flow in bone marrow Vs QIP-Mass spectrometry in peripheral blood to assess minimal residual disease in newly diagnosed multiple myeloma patients receiving maintenance as part of the GEM2014MAIN Trial. Blood; Presented at ASH 2022; 140:866a
4. Puig N, et al. Analysis of treatment efficacy in the GEM-CESAR trial for high-risk smoldering multiple myeloma patients: Comparison between the standard and IMWG MRD criteria and QIP-MS including FLC (QIP-FLC-MS). J Clin Oncol 2020; 38:8512a
5. Berlanga O, et al. Two cases of multiple myeloma achieving complete remission but presenting residual M-protein by the EXENT® solution. Presented at AACC 2023; B371a
6. Puig N, et al. QIP-Mass Spectrometry in high risk smoldering multiple myeloma patients included in the GEM-CESAR Trial: Comparison with Conventional IMWG Response Assessment. Presented at AACC 2020; B-341a
7. Derman BD, et al. Comparison of monoclonal gammopathy assessed by mass spectrometry vs. serum protein immunofixation in peripheral blood in Multiple Myeloma. Presented at AACC 2020; B-351aa
8. Lajko M, et al. Using QIP-MS to distinguish a therapeutic mAb from an endogenous M-protein in patients being treated for multiple myeloma. Presented at AACC 2018; A-328a
9. Mai EK, et al. Implications and prognostic impact of mass spectrometry in patients with newly-diagnosed multiple myeloma. Blood; Presented at ASH 2022; 140:968a
10. Dispenzieri A, et al. N-glycosylation of monoclonal light chains on routine MASS-FIX testing is a risk factor for MGUS progression. Leukemia 2020