First-Of-Its-Kind Automated System Speeds Myeloma Diagnosis
Posted on 08 Dec 2025
More than 176,000 people are diagnosed with multiple myeloma worldwide each year, yet the current diagnostic pathway can be slow and uncertain, often relying on a highly subjective interpretation of test results. Now, a first-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers, and improved laboratory workflow to support fast, confident diagnosis of multiple myeloma.
Thermo Fisher Scientific (Waltham, MA, USA) has introduced the EXENT Analyzer and Immunoglobulin Isotypes (GAM) Assay, a first-of-its-kind automated platform for clinical laboratories. The EXENT System combines enhanced sensitivity and automation to provide accurate results, helping clinicians make a fast diagnosis for patients with multiple myeloma and related disorders.
The EXENT System is designed to address current diagnostic challenges by detecting and isotyping M-proteins, abnormal antibodies produced by cancerous plasma cells, at low concentrations. By providing clear, automated results that reduce the need for interpretation, the system gives clinicians a reliable view of a patient’s condition and supports early, confident diagnoses.
With its enhanced sensitivity, the EXENT System can precisely identify M-proteins based on their unique molecular weight, enabling clear detection of naturally occurring endogenous proteins and flagging known exogenous M-proteins, such as those derived from therapeutic antibodies. This capability offers clinicians critical insights into disease status, reinforcing the system’s role as a transformative tool for the diagnosis of multiple myeloma, smoldering multiple myeloma, Waldenström's macroglobulinaemia, and amyloid light chain amyloidosis, and for the evaluation of monoclonal gammopathy of undetermined significance.
The EXENT System, which has received 510(k) clearance from the US FDA and authorization for sale from Health Canada, is designed for routine use in clinical laboratories, combining advanced technology with ease of operation. With up to six hours of total walkaway time per shift, the system improves workflow efficiency and requires no prior mass spectrometry experience, making it accessible to a wide range of laboratories.
“Our continued goal is to equip laboratories and clinicians with technologies that deliver greater accuracy, efficiency and clarity, enabling more informed clinical decisions and improving the patient journey,” said Stephen Harding, vice president and general manager, protein diagnostics, Thermo Fisher Scientific. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”
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