Thermo Fisher Scientific announced that it has received an extended 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Optilite Freelite assays for evaluating monoclonal gammopathy of undetermined significance (MGUS), a precursor to multiple myeloma.
MGUS is a lifelong condition characterized by the presence of abnormal monoclonal proteins in the blood; it affects approximately 3% of the U.S. population age 50 and older. Rarely, the disorder may progress to multiple myeloma or other monoclonal gammopathies, including amyloid light-chain (AL) amyloidosis or lymphoproliferative disorders, such as Waldenström's macroglobulinemia. Therefore, once the presence of MGUS is identified, it is important to continually evaluate the monoclonal protein, including serum free light-chain (FLC) concentrations.
The Freelite assays are used to diagnose and measure monoclonal gammopathies as part of a workflow along with other assays. They measure kappa and lambda FLCs in serum so that even small concentrations of monoclonal FLC proteins that are undetectable by serum protein electrophoresis can be identified, Thermo Fisher said in a statement.
The assays have previously received 510(k) clearance for the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, AL amyloidosis, light-chain deposition disease, and connective tissue diseases such as systemic lupus erythematosus.
The Freelite assays were developed by The Binding Site Group, a Birmingham, U.K.-based specialty diagnostics firm. Thermo Fisher acquired The Binding Site Group in 2022 for approximately $2.6 billion. The assays were the first commercially available FLC tests and are used in over 1,000 laboratories worldwide, including some of the largest multiple myeloma centers, the company said.
Thermo Fisher noted that attendees of the Association for Diagnostics & Laboratory Medicine annual meeting, which is being held from July 28 to August 1 in Chicago, can learn more about the Freelite assays at the company’s booth ( No. 2213).
