Thermo Fisher Scientific has commercially rolled out the EXENT Solution in select European countries upon securing In Vitro Diagnostic Regulation (IVDR) certification in the European Union (EU).

The EXENT solution is a fully automated, integrated mass spectrometry system.

The medical technology major has designed the solution for diagnosis, evaluation, and monitoring of patients with monoclonal gammopathies, including multiple myeloma and Waldenström’s macroglobulinemia.

Thermo Fisher Scientific said that the EXENT Solution is now available commercially in Belgium, Germany, France, Italy, Spain, the Netherlands, and the UK.

According to Thermo Fisher, the product offers improved analytical sensitivity and specificity to laboratories to measure, quantify, and monitor exogenous therapeutic monoclonal antibodies and endogenous M-proteins in serum.

It has three integrated modules which are said to be simple to use in routine laboratory work. These include EXENT-iP500, an automated sample preparation device, and EXENT-iX500, a Matrix Assisted Laser Desorption Ionisation – Time of Flight Mass Spectrometer (MALDI-ToF MS).

The third module is EXENT-iQ, a smart and user-friendly workflow software that includes data review.

Additionally, the analyser is combined with the EXENT Immunoglobulin Isotypes (GAM) immunoassay, a specific and highly sensitive immunoassay to calculate and quantify IgG, IgA, and IgM.

Thermo Fisher protein diagnostics chief scientific officer Stephen Harding said: “The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins.”

The medical technology provider claimed that the latest offering is a more sensitive analytical method than traditional techniques. The solution can differentiate between subsets, without starting early invasive bone marrow biopsy techniques.

The EXENT Solution is said to have capabilities for dynamic monitoring of M-proteins, thus allowing the identification of additional M-proteins created by emerging clones.

It also has advanced visualisation feature to present M-proteins in a visually intuitive manner, helping in making informed decisions about endogenous M-proteins.

Furthermore, the IVDR-certified product requires a simplified and minimally invasive serum test, Thermo Fisher said.

Additional features include a smart software with automated algorithm data processing and quantification with the Optilite Analyser.