Thermo Fisher Scientific has received extended US Food and Drug Administration (FDA) 510k clearance for its Optilite Freelite assays, allowing for the evaluation of monoclonal gammopathy of undetermined significance (MGUS).
MGUS is considered to be a precursor to multiple myeloma.
The Optilite Freelite assays are designed to support the diagnostic and monitoring processes for monoclonal gammopathies, alongside various other laboratory tests.
The assays offer healthcare professionals with a highly sensitive and precise method for measuring kappa and lambda free light chains (FLC) in serum. According to Thermo Fisher Scientific, this enables the detection of even trace amounts of monoclonal FLC proteins that might not be visible through serum protein electrophoresis.
Previously, the Optilite Freelite assays obtained 510(k) clearance from the FDA for diagnosing and monitoring multiple myeloma, Waldenström’s macroglobulinemia, lymphocytic neoplasms, light chain deposition disease, amyloid light-chain amyloidosis, and connective tissue diseases like systemic lupus erythematosus.
As the first commercially available FLC tests, Optilite Freelite assays are used in over 1,000 laboratories globally, including many major multiple myeloma centres, the biotechnology firm claimed.
Thermo Fisher Scientific protein diagnostics vice president and general manager Hamid Erfanian said: “Our easy-to-use Freelite assays are trusted by healthcare professionals globally, and with the new claim, and as a key part of laboratory diagnostics tools, we can help healthcare providers continually evaluate patients with MGUS, which is important to understand the disorder and the progression to pathological malignancies.
“Earlier identification of MGUS will enable more effective monitoring of disease progression and need for treatment, ultimately improving patient outcomes.”
The Freelite assays were originally developed by Binding Site Group, a UK-based speciality diagnostics firm, which was acquired by Thermo Fisher Scientific last year for $2.6bn.
The acquisition of Binding Site added protein diagnostics solutions, including diagnosis and monitoring for monoclonal gammopathies, to the biotechnology firm’s speciality diagnostics portfolio.
