Thermo Fisher Scientific, announced the commercial launch of the EXENT Solution, after receiving IVDR certification*. The EXENT solution is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies, including multiple myeloma.
The EXENT Solution enables clinical laboratories to measure, quantify and track specific endogenous M-proteins and exogenous therapeutic monoclonal antibodies with enhanced analytical sensitivity and specificity in serum, according to Thermo Fisher.
The EXENT Solution is easy to implement in routine laboratory use and features three integrated modules: EXENT-iP500, an automated sample preparation instrument; EXENT-iX500, a Matrix Assisted Laser Desorption Ionization – Time of Flight Mass Spectrometer (MALDI-ToF MS); and EXENT-iQ, an intelligent and intuitive workflow software, including data review. The analyser is combined with the EXENT Immunoglobulin Isotypes (GAM) immunoassay, a highly sensitive and specific immunoassay for measuring and quantifying IgG, IgA, and IgM.
“The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins,” says Stephen Harding, chief scientific officer, Protein Diagnostics, Thermo Fisher.
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Traditionally, treatment for monoclonal gammopathies is determined by monitoring M-protein levels, which can indicate tumor size. With notable treatment successes in recent years, many patients are achieving M-protein concentrations below detectable limits using standard techniques. However, differences in disease progression persist within this group. The EXENT Solution addresses this unmet clinical need for more sensitive analytical methods that can differentiate between subsets, without initiating invasive bone marrow biopsy techniques too early.
The EXENT Solution was developed with Mayo Clinic intellectual property, combining industry leadership in innovation with Mayo’s expertise in monoclonal gammopathy research. The EXENT Solution is intended to aid diagnosis of monoclonal gammopathies and monitoring of multiple myeloma and Waldenström’s macroglobulinemia patients.
Key features and innovations of the EXENT Solution include: enhanced analytical sensitivity; dynamic monitoring of unique M-proteins; advanced visualization; simplified and less invasive serum testing; smart software with automated algorithm data processing; and quantification capabilities with the Optilite Analyser.
Earlier this year, Thermo Fisher Scientific completed the acquisition of The Binding Site, adding protein diagnostics solutions, including diagnosis and monitoring for monoclonal gammopathies, to its specialty diagnostics portfolio, according to the company.
*The EXENT Solution consists of the following CE marked products: EXENT Analyser, IE800 (IVDR Class A, nonsterile), Immunoglobulin isotypes (GAM) for the EXENT Analyser – MSR801.M (IVDR Class C), EXENT Immunoglobulin Isotypes (GAM) Control Pack – MSQ801.M (IVDR Class C).
Featured image: Thermo Fisher’s EXENT Solution. Photo: Thermo Fisher