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

First-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers and improved laboratory workflow to support fast, confident diagnoses

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 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, smoldering multiple myeloma, Waldenström's macroglobulinaemia and amyloid light chain amyloidosis, and as an 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.

To learn more about the EXENT System, please visit https://www.thermofisher.com/bindingsite/us/en/products/instruments/exent-system.html.

*The EXENT® System combines EXENT® Analyser with the Immunoglobulin Isotypes (GAM) for the EXENT® Analyser

**EXENT GAM Assay refers to Immunoglobulin Isotypes (GAM) for the EXENT® Analyser

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.

EXENT, EXENT iQ, EXENT iX, and EXENT iP and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries. Product availability is subject to country specific regulatory requirements. Contact your local representative for availability in your country.

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 M‑protein or when serum free light chains are abnormal.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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