October 2024—Thermo Fisher Scientific announced it received FDA 510(k) clearance to market its Optilite Freelite assays for the evaluation of monoclonal gammopathy of undetermined significance. The assays measure kappa and lambda free light chains in serum, enabling the identification of even small concentrations of monoclonal FLC proteins undetectable by serum protein electrophoresis.
Other Freelite assays that have received 510(k) clearance include those for the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom macroglobulinemia, AL amyloidosis, light chain deposition disease, and connective tissue diseases such as systemic lupus erythematosus.
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