Thermo Fisher’s EXENT System Receives FDA Clearance, Revolutionizing Multiple Myeloma Diagnostics

Thermo Fisher Scientific Inc. has received FDA 510(k) clearance for its EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay, marking a breakthrough in automated diagnostics for multiple myeloma and related disorders. This innovative platform integrates high sensitivity and automation, enabling clinical laboratories to deliver faster and more accurate results, ultimately helping clinicians reach a timely and confident diagnosis.

“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.”

Multiple myeloma affects more than 176,000 people globally each year, and current diagnostic processes often rely on manual interpretation of complex test results. The EXENT System addresses this gap by automating the detection and isotyping of M-proteins—abnormal antibodies produced by malignant plasma cells, at very low concentrations. By providing clear, objective data, the system reduces diagnostic uncertainty and supports early identification of conditions such as multiple myeloma, Waldenström’s macroglobulinaemia, amyloid light chain amyloidosis, and monoclonal gammopathy of undetermined significance (MGUS).

“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.”

Designed for routine use in clinical laboratories, the EXENT System offers up to six hours of walkaway time per shift and does not require prior mass spectrometry experience, improving both accessibility and workflow efficiency. Following FDA clearance and Health Canada authorization, the system is now commercially available for clinical use in multiple regions, including the U.S., Canada, Australia, and across major European markets. Thermo Fisher’s launch of the EXENT platform underscores its commitment to advancing precision diagnostics and improving outcomes for patients with plasma cell disorders.