July 31, 2024- Thermo Fisher Scientific Inc., the world leader in serving science, today 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). MGUS affects an estimated 3% of the U.S. population over 50 and is a lifelong condition where abnormal monoclonal proteins are found in a patient’s blood. Once identified, it is important to continually evaluate the monoclonal protein, including serum free light chain serum concentrations as, rarely, the disorder progresses to Multiple Myeloma and other monoclonal gammopathies such as light chain amyloidosis or lymphoproliferative disorders such as Waldenström’s macroglobulinemia.
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.