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Thermo Fisher Scientific’s EXENT, a first-of-its-kind solution to support fast, clear diagnosis of multiple myeloma, receives FDA clearance

The automated system delivers increased sensitivity and specific identification of disease markers to support fast, confident diagnoses

By Terri Somers
Senior Manager, Global PR and StoryLab

WALTHAM, Mass., (Nov. 12, 2025) – Patients and their physicians in the United States concerned that abnormal blood test results may be indicative of multiple myeloma, an incurable type of blood cancer, or other severe health conditions, now have a test available to confirm a diagnosis quickly.  Thermo Fisher Scientific’s EXENT System, a first-of-its-kind mass spectrometry platform, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of multiple myeloma and other conditions.

“The clearance of the EXENT System represents a significant advancement in the tools available to aid in the diagnosis of multiple myeloma,” said Dr. Noemi Puig, a consulting physician at the Department of Hematology, University Hospital Salamanca, and leader in multiple myeloma clinical research. “By combining increased sensitivity with ease of use and automated workflows, laboratories can achieve greater clarity and diagnostic confidence, ultimately supporting improved patient care.”

FDA Clears Thermo Fisher’s EXENT to aid in confirming the diagnosis of multiple myeloma.

More than 176,000 people are diagnosed with multiple myeloma worldwide each year, according to the International Myeloma Foundation (IMF). The current diagnostic pathway can be slow and uncertain, often relying on a highly subjective interpretation of test results. The EXENT System is designed to address these challenges.

 

Tests for myeloma look for an accumulation of monoclonal, or “M”, proteins produced by plasma cells, which may indicate disease. The EXENT System can precisely identify M-proteins by their unique molecular weights even at low concentrations. This capability offers clinicians critical insights into disease status.

These insights make it an important tool as an aid in the diagnosis of multiple myeloma, smoldering myeloma, which is the cancer’s early stage with no sign of organ damage, as well as Waldenstrom’s macroglobulinemia and amyloid light chain amyloidosis, the company said in a press release. It also supports the evaluation of monoclonal gammopathy of undetermined significance (MGUS), a lower level of M-protein accumulation. Some patients with MGUS and smoldering multiple myeloma will progress to multiple myeloma.

 

  “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 of Thermo Fisher’s protein diagnostics business.  “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”

 

The EXENT System is a combination of a serum (blood) test, the Immunoglobulin Isotypes (GAM), with the EXENT® Analyzer. In addition to now being cleared for clinical use in the U.S., the EXENT System is also available in Belgium, Brazil, Canada, France, Germany, Italy, the Netherlands, New Zealand, Spain, the United Kingdom, Switzerland, and Australia.

 

  • The EXENT Immunoglobulin Isotypes (GAM) for the EXENT Analyser test system has not been evaluated for use in post-diagnostic patient monitoring of monoclonal gammopathies.

  • United States market information only: Rx only. Serum matrix only. Results require valid Optilite® IgG/IgA/IgM results on the Optilite Analyser. For use as a reflex test when serum protein electrophoresis suggests an Mprotein or when serum free light chains are abnormal

  • EXENT and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries.