SEBIA
29.2.2024 19:31:27 CET | Business Wire | Press release
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.
-End-
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229662488/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Visa Threats Report: As Network Security Strengthens, Criminals Accelerate Shift to AI-Enabled Social Engineering20.5.2026 15:16:00 CEST | Press release
Spring 2026 Biannual Threats Report shows how strengthening payment security is pushing criminals toward AI-enabled social engineering Visa (NYSE: V), a world leader in digital payments, today released its Spring 2026 Biannual Threats Report, revealing that scams have become the fastest-growing source of consumer harm as criminals increasingly use artificial intelligence and social engineering to manipulate people into authorizing payments themselves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520153924/en/ The report draws on intelligence from Visa’s global network and underscores a critical shift in the fraud landscape: while core payment security continues to strengthen at the network level, criminals are redirecting their efforts away from technical system compromises toward exploiting human trust. From July to December 2025, Visa identified nearly $1 billion in scam-related activity, making scams the single large
1GLOBAL Launches Verint Communications Analytics to Enhance Cloud Compliance for Financial and Regulated Industries20.5.2026 15:00:00 CEST | Press release
1GLOBAL now offers transcription with insights into mobile calls in 10 countries on Verint Communications Analytics, built specifically for financial markets and trading environmentsStreamlines the compliance investigation and mobile call monitoring process through transcription and analysisSupports transcription and translation from 30+ languages into English with near real-time processing 1GLOBAL, a pioneer in global telecommunications solutions, today announced its launch of Verint® Communications Analytics, a key offering within Verint Financial Compliance (VFC) providing mobile call transcription and analytics capabilities. Verint Communications Analytics has been designed to help financial institutions and regulated organizations accelerate productivity when monitoring voice calls (including mobile), identifying behavioral patterns, querying data intentionally by topic, risks, keywords or sentiment, identifying misuse and reducing regulatory risk. Verint Communications Analytics
Xsolla Expands Nordic Presence With Industry Engagements Across Sweden, Including Official Sponsorship of Nordic Game 202620.5.2026 15:00:00 CEST | Press release
Coordinated Activations Across Sweden Underscore Xsolla’s Continued Investment In The Nordic Games Ecosystem, Bringing Developers, Partners, And Creators Together Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announces a comprehensive program of events and activations across Sweden throughout May 2026, including its official sponsorship of Nordic Game 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520833786/en/ Graphic: Xsolla At Nordic Game, Xsolla will showcase its Web Shop solution, a direct-to-consumer (D2C) platform designed to help developers build and scale their own storefronts outside traditional app stores. The Web Shop ecosystem integrates storefronts, LiveOps tools, and player engagement features, enabling studios to strengthen player relationships while increasing revenue and operational control. Xsolla will also highlight its global pay
Cyclic Materials Appoints Former Siemens and Alcoa CEO Klaus Kleinfeld to Board of Directors20.5.2026 14:30:00 CEST | Press release
Dr. Klaus Kleinfeld’s proven leadership at two Fortune 500 public companies will strengthen the company’s global expansion Cyclic Materials, the rare earth recycling company enabling domestic circular supply chain for critical materials around the world, today announced the appointment of Dr. Klaus Kleinfeld to its Board of Directors. Dr. Kleinfeld brings decades of experience leading global industrial and advanced manufacturing businesses, including serving as CEO of two Fortune 500 companies – Siemens AG and Alcoa. His experience growing complex international operations, navigating global markets, and leading large industrial transformations will support Cyclic Materials’ industrial expansion to meet an accelerating global demand. An internationally recognized executive, investor, and entrepreneur, Dr. Kleinfeld has advised multiple U.S. Presidents and global leaders on industrial competitiveness, technology, and economic development. “Cyclic Materials is scaling a strategically vita
HTEC and Motion Applied: Collaboration Built on Performance, Precision, and Innovation20.5.2026 14:18:00 CEST | Press release
HTEC, a global AI-first engineering and digital product development company, and Motion Applied are expanding their collaboration following a successful track record in developing advanced solutions across multiple industries. Motion Applied delivers engineering and technology solutions in motorsport, electrification and transportation, bringing 35 years of top-tier motorsport heritage and race-honed engineering excellence to the development of high-performance systems and their application beyond the track. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520285726/en/ HTEC, a global AI-first engineering and digital product development company, and Motion Applied are expanding their collaboration following a successful track record in developing advanced solutions for the motorsport and transportation industry. The two companies have worked closely on complex engineering initiatives, contributing to the advancement of high
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom