Thermo Fisher Scientific announces extended 510k Clearance of Freelite Assays for evaluation of MGUS, a precursor to multiple myeloma
Thermo Fisher Scientific Inc. announced it has been 510k cleared, following US Food and Drug Administration (FDA) requirements, to market its Optilite Freelite assays’ claim for the evaluation of monoclonal gammopathy of undetermined significance (MGUS).
Alongside other laboratory tests, Freelite assays are used as part of a workflow for diagnosing and monitoring monoclonal gammopathies. The assays provide healthcare professionals with a highly sensitive and accurate way to measure kappa and lambda free light chains (FLC) in serum, enabling the identification of even small concentrations of monoclonal FLC proteins in patients undetectable by serum protein electrophoresis.
Freelite assays previously received 510k clearance, following US Food and Drug Administration (FDA) requirements, 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 (SLE).
In 2023 Thermo Fisher Scientific completed the acquisition of The Binding Site, adding protein diagnostics solutions, including diagnosis and monitoring for monoclonal gammopathies, to its specialty diagnostics portfolio. Attendees of the Association for Diagnostics and Laboratory Medicine (ADLM) Annual Meeting, taking place from July 28 to August 1, 2024 in Chicago, Ill., can learn more about how Freelite can help support their laboratories in Thermo Fisher’s booth (#2213).
