Sebia receives U.S. FDA Clearance for the FLC Kappa & Lambda assays
Expanding offering for Multiple Myeloma and AL Amyloidosis Testing.
Sebia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the FLC Kappa & Lambda assays.
These are the first EIA tests receiving 510(k) from the FDA for the quantitative detection of both kappa and lambda free light chains (FLC) in human serum specimens, intended for both aid of diagnosis and monitoring of #Multiple Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.
As a global leader for multiple myeloma testing, Sebia expands its offer in the U.S. with this new solution, easily adaptable to automated immunoassay instruments for a high throughput processing. The ELISA format overcomes main challenges in analytical performance often seen in alternative testing methods