By Melissa Badamo - Last Updated: March 7, 2024
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Sebia’s free light chain (FLC) kappa and lambda assays, according to a press release from Sebia, a global specialty diagnostic company. These quantitative enzyme immunoassay (EIA) tests are used to aid in the diagnosis and monitoring of plasma cell disorders such as multiple myeloma (MM) and immunoglobulin light chain (AL) amyloidosis by detecting kappa and lambda FLCs in human serum specimens. The FLC kappa and lambda assays had a comparable clinical sensitivity of 96.6% in 177 samples from patients diagnosed with MM and an improved clinical specificity of 85.1% in 189 patients with clinical conditions other than MM and amyloidosis, the company reported.
Original Source: FDA Grants 510(k) Clearance to Sebia’s FLC Kappa, Lambda Assays for MM Diagnosis | Blood Cancers Today