NEW YORK — Thermo Fisher Scientific said Monday that its Optilite Freelite assays have received 510(k) clearance from the US Food and Drug Administration for use in evaluating monoclonal gammopathy of undetermined significance (MGUS).
MGUS, which is characterized by the presence of abnormal monoclonal proteins in the blood, affects around 3 percent of the US population over 50 years of age, according to Thermo Fisher. Continuous evaluation of the proteins, including serum free light chain serum concentrations, is required, as the disorder sometimes progresses to multiple myeloma and other monoclonal gammopathies.
Freelite assays are designed to measure kappa and lambda free light chains (FLCs) in serum, so that even small concentrations of monoclonal FLC proteins that are undetectable by serum protein electrophoresis can be identified, the company said.
The assays previously received 510(k) clearance from the FDA 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. They were developed by UK-based specialty diagnostics firm The Binding Site Group, which Waltham, Massachusetts-based Thermo Fisher acquired in late 2022 for about $2.6 billion in cash.