Thermo Fisher Scientific Receives 510(k) Clearance for EXENT® System for Multiple Myeloma Diagnosis

Thermo Fisher Scientific has received 510(k) clearance in the United States for the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay. 

The system is the first fully automated platform developed to support laboratories in identifying and classifying abnormal antibodies linked to multiple myeloma and similar disorders.

Multiple myeloma can be challenging to diagnose, as existing methods often depend on manual interpretation of complex laboratory results. The EXENT System aims to address this issue by combining increased sensitivity with automated workflows. 

It detects M-proteins at low concentrations and assigns their type, giving clinicians clearer and more dependable information about a patient’s condition at an earlier stage in the diagnostic pathway.

The technology identifies M-proteins based on their molecular weight, allowing it to separate natural proteins from those that may come from therapeutic treatments. 

This provides relevant insights for clinicians when assessing conditions such as multiple myeloma, smouldering multiple myeloma, Waldenström’s macroglobulinaemia, amyloid light chain amyloidosis and monoclonal gammopathy of undetermined significance.

The EXENT System is designed for everyday use in clinical laboratories. It offers extended walkaway time to support workflow efficiency and does not require specialist mass spectrometry experience.