WALTHAM, Mass. — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that its EXENT Analyser and Immunoglobulin Isotypes (GAM) Assay have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The EXENT System is the first fully automated platform of its kind for clinical laboratories, offering enhanced sensitivity, specific identification of disease markers, and improved workflow to support faster, more confident diagnoses for multiple myeloma and related disorders.
Multiple myeloma affects more than 176,000 people worldwide each year, according to the International Myeloma Foundation. Traditional diagnostic methods can be slow and subjective, often requiring manual interpretation of complex test results. The EXENT System addresses these limitations by detecting and isotyping M-proteins—abnormal antibodies produced by malignant plasma cells—at very low concentrations. Its automated processes provide clinicians with clear, reproducible results, reducing interpretation time and uncertainty.
“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, 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.”
Using advanced mass spectrometry-based detection, the EXENT System identifies M-proteins by their molecular weight, distinguishing between naturally occurring endogenous proteins and therapeutic antibody-derived exogenous proteins. This capability enables precise assessment of disease status and supports diagnosis of multiple myeloma, smoldering multiple myeloma, Waldenström’s macroglobulinemia, amyloid light chain amyloidosis, and monoclonal gammopathy of undetermined significance.
“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 protein diagnostics at Thermo Fisher Scientific. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”
Designed for routine use, the EXENT System combines high performance with user-friendly operation, requiring no prior mass spectrometry experience and offering up to six hours of walkaway time per shift. The system has also received authorization for sale from Health Canada.
Following its FDA 510(k) clearance and clinical validation, the EXENT System is now available for clinical use in the United States as well as in Australia, Belgium, Brazil, Canada, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland, and the United Kingdom.
