FDA 510(k) clearance for Thermo’s Freelite assays is extended
Thermo Fisher Scientific (MA, USA) has announced the receipt of an extended 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Optilite Freelite assays. These assays allow the evaluation of monoclonal gammopathy of undetermined significance (MGUS), a precursor to myeloma, which is a cancer that develops from plasma cells in the bone marrow.
MGUS is characterized by the presence of abnormal monoclonal proteins in the blood and in rare cases can progress to multiple myeloma or other monoclonal gammopathies. It is therefore critical to monitor levels of the monoclonal protein once a patient has been diagnosed with MGUS, including serum free light-chain (FLC) concentrations.
The Freelite assays are used to diagnose and measure monoclonal gammopathies in combination with a range of other assays. They measure kappa and lambda FLCs in serum — the two types of FLCs present in the blood — which, together with heavy chains, form immunoglobins. The Freelite assays can measure kappa and lambda FLC levels small enough to be missed by serum protein electrophoresis and were the first commercially available FLC tests.
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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 assays are used in over 1000 laboratories worldwide, including some of the largest multiple myeloma centers.
