Sebia Receives U.S. FDA Clearance for the FLC Kappa & Lambda Assays
Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it 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 in human serum specimens, intended for both aid of diagnosis and monitoring of Multiple Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.
Clinical evaluation of Sebia FLC kappa and FLC lambda assay has shown comparable clinical sensitivity with the Freelite assay (96.6% on 177 samples from patients diagnosed with MM) and improved clinical specificity (85.1% on 189 non-myeloma/non-amyloidosis subjects with various clinical conditions). These excellent performances have been notably highlighted in the Willrich et al publication released in 2022.
“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” said Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality.
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ABOUT Sebia
Founded in 1967, Sebia is a world-leading provider of clinical protein electrophoresis equipment and reagents, a technology used for in vitro diagnostic testing. Its systems analyze proteins in order to screen and monitor various diseases and conditions; primarily oncology (multiple myeloma) and metabolic disorders such as diabetes, also hemoglobinopathy and rare pathologies.
Following the acquisition of Orgentec, Corgenix, Arotec in 2021, and of Zeus Scientific in 2022, Sebia now develops and markets innovative solutions for autoimmunity diagnostics.
Headquartered in Lisses, France, the company operates across more than 120 countries. Sebia is owned by CVC Capital Partners, Tethys Invest and the Caisse de Dépôt et Placement du Quebec (CDPQ).
https://www.sebia.com
References
1. Willrich MAV, Murray DL, Rajkumar SV, et al. Comparison of two free light chain assays: performance of the involved free light chain ratio and implications for diagnosis of multiple myeloma. Blood Cancer J. 2022;12(9):127. Published 2022 Sep 2. doi:10.1038/s41408-022-00722-5
2. Lakshman A, Rajkumar SV, Buadi FK, et al. Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria. Blood Cancer J. 2018;8(6):59. Published 2018 Jun 12. doi:10.1038/s41408-018-0077-4
3. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-e548. doi:10.1016/S1470-2045(14)70442-5
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