Thermo Fisher Scientific received 510(k) clearance from the U.S. Food and Drug Administration on November 12, 2025, for its EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay. The clearance authorizes the company to market the EXENT System in the United States, giving clinicians a rapid, highly sensitive automated platform for detecting and isotyping monoclonal proteins that signal multiple myeloma and related disorders.
The EXENT System combines advanced immunoassay chemistry with a fully automated workflow that can detect low‑concentration M‑proteins in a single run. By providing objective, high‑resolution results, the platform reduces the subjectivity and turnaround time that currently characterize laboratory diagnosis of monoclonal gammopathies. The system’s sensitivity allows earlier detection of disease progression and can support timely therapeutic decisions.
Multiple myeloma affects more than 176,000 people worldwide each year, yet the diagnostic pathway remains fragmented and slow. The global cancer diagnostics market is projected to reach $148.2 billion by 2035, growing at a CAGR of 8.5 %. By entering the U.S. market, Thermo Fisher taps a sizable share of this expanding segment, positioning the company to capture incremental revenue from a high‑growth, high‑margin diagnostic niche.
The clearance follows a series of international approvals that began with an IVDR certification in Europe in August 2023 and subsequent authorizations in Canada, Australia, and other markets. Thermo Fisher’s acquisition of The Binding Site in early 2024 added complementary protein‑diagnostics capabilities, and the EXENT System leverages intellectual property from the Mayo Clinic to strengthen the company’s portfolio. In mid‑2025, Thermo Fisher explored divesting parts of its diagnostics business valued at roughly $4 billion, a move that underscores its focus on high‑growth, high‑margin assets such as the EXENT System.
Dr. Noemi Puig, a leading multiple‑myeloma researcher, said the clearance “represents a significant advancement in the tools available to aid in the diagnosis of multiple myeloma. By combining increased sensitivity with ease of use and automated workflows, laboratories can achieve greater clarity and diagnostic confidence, ultimately supporting improved patient care.” The addition of the EXENT System is expected to strengthen Thermo Fisher’s competitive edge in precision medicine and could drive incremental revenue as laboratories adopt the platform to meet growing demand for rapid, accurate diagnostics.
The FDA clearance marks a key regulatory milestone for Thermo Fisher and signals the company’s continued investment in oncology diagnostics. With the EXENT System now available in the United States, Thermo Fisher is positioned to accelerate its growth in the precision‑medicine space and to reinforce its strategy of focusing on high‑growth diagnostic assets.
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