Global Finance News
12 Nov 2025, 19:35
Thermo Fisher Scientific announced that its EXENT System has received 510(k) clearance from the U.S. Food and Drug Administration, marking the first automated platform designed to aid in diagnosing multiple myeloma and related disorders.
The EXENT Analyser and Immunoglobulin Isotypes (GAM) Assay provide high sensitivity and specific identification of M-proteins—abnormal antibodies produced by cancerous plasma cells—helping clinicians detect disease markers at very low concentrations. The system automates analysis to minimize subjective interpretation, accelerating and improving diagnostic accuracy for multiple myeloma, smoldering myeloma, Waldenström’s macroglobulinaemia, amyloidosis, and monoclonal gammopathy of undetermined significance.
Thermo Fisher stated that the EXENT System also improves laboratory workflow with up to six hours of walkaway time per shift and requires no mass spectrometry experience, broadening accessibility for clinical labs. Having already received Health Canada authorization, the system is now available for clinical use in 13 countries, including the U.S., U.K., Germany, France, and Australia.
Vice President Stephen Harding said the platform underscores Thermo Fisher’s mission to equip clinicians with tools that enhance diagnostic confidence and patient care through greater precision and efficiency.
The EXENT Analyser and Immunoglobulin Isotypes (GAM) Assay provide high sensitivity and specific identification of M-proteins—abnormal antibodies produced by cancerous plasma cells—helping clinicians detect disease markers at very low concentrations. The system automates analysis to minimize subjective interpretation, accelerating and improving diagnostic accuracy for multiple myeloma, smoldering myeloma, Waldenström’s macroglobulinaemia, amyloidosis, and monoclonal gammopathy of undetermined significance.
Thermo Fisher stated that the EXENT System also improves laboratory workflow with up to six hours of walkaway time per shift and requires no mass spectrometry experience, broadening accessibility for clinical labs. Having already received Health Canada authorization, the system is now available for clinical use in 13 countries, including the U.S., U.K., Germany, France, and Australia.
Vice President Stephen Harding said the platform underscores Thermo Fisher’s mission to equip clinicians with tools that enhance diagnostic confidence and patient care through greater precision and efficiency.
