Morningstar

Thermo Fisher Gets FDA Clearance for System to Aid in Multiple Myeloma Diagnosis

Provided by Dow Jones Nov 12, 2025, 1:45:00 PM

By Nicholas G. Miller

Thermo Fisher Scientific received 510(k) clearance from the Food and Drug Administration to market its EXENT system to aid in the diagnosis of multiple myeloma.

The company's EXENT system detects and isotypes M-proteins, abnormal antibodies produced by cancerous plasma cells, at low concentrations.

Thermo Fisher said the system would allow clinicians to more quickly and accurately make a fast diagnosis for patients with multiple myeloma and related disorders.

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.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

November 12, 2025 08:45 ET (13:45 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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