November 12, 2025- Thermo Fisher Scientific Inc. announced 510(k) clearance of the EXENT® Analyser 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.
According to the International Myeloma Foundation, 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 highly subjective interpretation of test results. The EXENT System is designed to address this challenge 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.
*The EXENT® System combines EXENT® Analyser with the Immunoglobulin Isotypes (GAM) for the EXENT® Analyser
**EXENT GAM Assay refers to Immunoglobulin Isotypes (GAM) for the EXENT® Analyser