Thermo Fisher Scientific Receives 510(k) Clearance in the United States for EXENT System* to Aid in the Diagnosis of Multiple Myeloma

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced 510(k) clearance of the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay**, a first-of-its-kind automated MALDI-ToF mass spectrometry 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 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.”

With its enhanced sensitivity, the EXENT System can precisely identify M-proteins based on their unique molecular weight, allowing for clear detection of naturally occurring endogenous proteins and flagging of 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 as an aid in the diagnosis of multiple myeloma, smouldering multiple myeloma, Waldenström's macroglobulinaemia and amyloid light chain amyloidosis, and aid in the evaluation of 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, protein diagnostics, Thermo Fisher Scientific. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”

The EXENT System, which has also recently received 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.

With the 510(k) clearance and clinical validation in the U.S., the EXENT System is now available for clinical use in the U.S., as well as in Australia, Belgium, Brazil, Canada, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland and the United Kingdom.