Thermo Fisher Scientific has received FDA 510(k) clearance for the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay, marking the launch of the first fully automated platform designed to support clinical laboratories in diagnosing multiple myeloma and related plasma cell disorders. The system integrates high sensitivity with automation to deliver clear, reliable results and streamline diagnostic workflows.
Multiple myeloma affects more than 176,000 people globally each year, yet diagnosis often remains slow and heavily dependent on subjective interpretation. The EXENT System aims to address this gap by detecting and isotyping M-proteins—abnormal antibodies produced by malignant plasma cells—even at low concentrations. The platform provides automated, objective output to help clinicians achieve earlier and more confident diagnoses.
The system precisely identifies M-proteins using their molecular weight, distinguishing natural endogenous proteins from exogenous ones, including those resulting from therapeutic antibodies. This level of detail supports diagnosis and evaluation across conditions such as multiple myeloma, smoldering multiple myeloma, Waldenström's macroglobulinaemia, amyloid light-chain amyloidosis and monoclonal gammopathy of undetermined significance.
Designed for routine clinical use, the EXENT System offers up to six hours of walkaway automation per shift and does not require prior mass spectrometry expertise, increasing accessibility for laboratories of varying capacities. The platform has also been authorized for sale by Health Canada.
With FDA clearance and validation, the EXENT System is now available for clinical use in the United States as well as Australia, Belgium, Brazil, Canada, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland and the United Kingdom.
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