FDA Authorizes EXENT System to Aid Myeloma Diagnosis

The FDA has granted 510(k) clearance to the EXENT System, a fully automated device for assessing monoclonal gammopathies, to aid in the diagnosis of multiple myeloma.¹ The system offers easy implementation and operation and enhances workflow efficiency, providing valuable utility for clinical laboratories.

The EXENT System was designed to address pressing diagnostic challenges in multiple myeloma. Multiple myeloma presents heterogeneously with nonspecific symptoms, often leading to subjective interpretations of test results and delays in diagnosis.²

With its 2 constituents, the EXENT Immunoglobulin Isotypes (GAM) Assay and EXENT Analyser, the system integrates immunoassay, mass spectrometry, and data review software to identify and measure monoclonal proteins in serum.³ The GAM Assay detects and isotypes monoclonal proteins at low concentrations, while the Analyser aids with interpretation of results with enhanced sensitivity and specificity, ensuring reliable results for clinicians.

The 510(k) clearance confirms that the EXENT System is substantially equivalent to a similar, legally marketed device in terms of safety and effectiveness,⁴ enabling its clinical use in the US. The device is also available in other markets, including Australia, Belgium, Brazil, Canada, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland, and the United Kingdom.

“The clearance of the EXENT System represents a significant advancement in the tools available to aid in the diagnosis of multiple myeloma,” Noemi Puig, MD, PhD, department of hematology at the University Hospital Salamanca, said in a news release.¹ “By combining increased sensitivity with ease of use and automated workflows, laboratories can achieve greater clarity and diagnostic confidence, ultimately supporting improved patient care.”

One study published in the Journal of Mass Spectrometry and Advances in the Clinical Lab provided practical insight into the performance of the EXENT System.⁵ By analyzing samples from patients with confirmed multiple myeloma, the study found that liquid chromatography-mass spectrometry (LC-MS) was able to detect monoclonal immunoglobulins that the EXENT System did not. Although EXENT demonstrates high sensitivity, the study suggests that at very low monoclonal protein concentrations, more sensitive tests like LC-MS may detect proteins that fall below EXENT’s sensitivity threshold.

Additionally, Thermo Fisher Scientific, developer of the EXENT System, has cautioned that while the device is valuable as a diagnostic aid, its performance has not been formally evaluated in postdiagnosis settings, such as for long-term monitoring of patients.

REFERENCES

1. Thermo Fisher Scientific receives 510(k) clearance in the United States for EXENT System to aid in the diagnosis of multiple myeloma. News release. Thermo Fisher Scientific. November 12, 2025. Accessed November 13, 2025. https://tinyurl.com/5es8bekd

2. Zorlu T, Kayer MA, Okumus N, et al. Challenges, difficulties, and delayed diagnosis of multiple myeloma. Diagnostics (Basel). 2025;15(13):1708. doi:10.3390/diagnostics15131708

3. EXENT System. Thermo Fisher Scientific. Accessed November 13, 2025. https://tinyurl.com/35av7z3s

4. Premarket notification 510(k). FDA. Updated August 22, 2024. Accessed November 13, 2025. https://tinyurl.com/4jxt6ezk

5. Barnidge D, Troske D, North S, Wallis G, Perkins M, Harding S. Endogenous monoclonal immunoglobulins analyzed using the EXENT solution and LC-MS. J Mass Spectrom Adv Clin Lab. 2024;32:31-40. doi:10.1016/j.jmsacl.2024.02.002