July 31, 2024 – Thermo Fisher Scientific Inc., the worldwide chief in offering scientific providers, immediately introduced that it has obtained 510k clearance, as required by the U.S. Meals and Drug Administration (FDA), to market the declare of its Optilite® Freelite® assays for the analysis of monoclonal gammopathy of undetermined significance (MGUS). MGUS impacts an estimated 3% of the U.S. inhabitants over the age of fifty. and is a lifelong situation during which irregular monoclonal proteins are present in a affected person's blood. As soon as recognized, you will need to regularly consider the monoclonal protein, together with serum free gentle chain concentrations, because the situation hardly ever progresses to a number of myeloma and different monoclonal gammopathies corresponding to gentle chain amyloidosis or lymphoproliferative issues corresponding to Waldenström's macroglobulinemia.

Together with different laboratory checks, Freelite assays are used as a part of a workflow to diagnose and monitor monoclonal gammopathies. The assays present healthcare professionals with a extremely delicate and correct solution to measure kappa and lambda free gentle chains (FLC) in serum, permitting identification of even small concentrations of monoclonal FLC proteins in sufferers that can not be detected by serum protein electrophoresis.

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