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
Operio Group Named Distributor for Schaefer Technologies in the United Kingdom and European Union9.3.2026 22:00:00 CET | Press release
Operio Group has signed a distribution agreement with Schaefer Technologies, a manufacturer of semi-automatic encapsulation equipment. Operio Group, a holding company building a global group of brands serving the solid dose manufacturing industry, will be the official distributor of Schaefer Technologies’ products in the United Kingdom and the European Union. Schaefer Technologies develops semi-automatic capsule filling systems, including equipment that produces banded capsules for liquid and pellet formulations used by nutraceutical and pharmaceutical manufacturers. Leadership from both companies worked together to establish the agreement, including Kevin Schaefer, CEO of Schaefer Technologies Inc., and Alastair Sanderson, Chief Business Development Officer at Operio Group. “Schaefer Technologies is looking forward to our new relationship with Operio Group,” said Schaefer. “Their understanding of the pharmaceutical equipment market makes them a strong partner as we combine our experti
Kinaxis Goes All-In on Innovation at Upcoming Kinexions in Las Vegas9.3.2026 19:00:00 CET | Press release
Annual customer conference will bring together global supply chain leaders to explore the latest trends, best practices and technologies in AI-powered planning, decision-making and agentic innovation Registration is officially open for Kinexions North America, the premier global supply chain orchestration conference hosted by Kinaxis® Inc. (TSX: KXS). Taking place June 1–3 in Las Vegas, Nevada, the event brings together supply chain leaders, innovators and practitioners from around the world to explore how organizations can leverage AI-driven strategies and technologies to connect data, people and decisions. After a year defined by market volatility, geopolitical risk and disruption, this year’s conference will focus on how intelligent supply chain orchestration enables organizations to move beyond reactive planning to building true enterprise adaptability. The program promises to be the most immersive and future-forward Kinexions yet, with renowned author, entrepreneur and innovation
InterSystems Appoints Former NHS and Mass General Leader Dr. Tim Ferris as Vice President, Healthcare Practice9.3.2026 17:00:00 CET | Press release
InterSystems, a creative data technology provider powering more than one billion health records globally, today announced the appointment of Tim Ferris, M.D., as Vice President, Healthcare Practice. The announcement comes as healthcare leaders gather for the 2026 HIMSS Global Health Conference & Exhibition. In this role, Dr. Ferris will leverage his comprehensive view of the industry to help drive the clinical and strategic direction of the company’s healthcare solutions worldwide. Drawing on his vast experience, he will serve as a strategic advisor to global health systems and governments, engineer targeted technology solutions based on real-world executive needs, advance his academic research on health data architecture and lead public discourse on the intersection of AI and care delivery. Dr. Ferris brings a unique global perspective to InterSystems that is virtually unmatched in healthcare. His career spans 30 years as a practicing primary care physician, executive leadership at pr
Radial Selects Riskified to Power Payment Fraud and Refund/Return Protection for Merchant Client Portfolio9.3.2026 15:00:00 CET | Press release
The partnership brings Riskified’s AI-powered platform for payment fraud, refund claim, and return abuse protection to Radial’s global network of merchants Riskified (NYSE: RSKD), a leader in ecommerce fraud and risk intelligence, today announced a strategic partnership with Radial, a leading 3PL set to become Paxon later this year. Radial will integrate with Riskified’s AI-powered platform to help its merchants approve more legitimate orders and reduce losses from payment fraud, including many merchants that use Shopify as their ecommerce platform. Radial supports many of the world’s most recognized retail brands with a global ecommerce fulfillment network of more than 20 centers across North America, helping merchants deliver orders quickly and cost effectively. By bringing Riskified’s AI-powered fraud decisioning into its commerce ecosystem, Radial gives merchants the surgical ability to calibrate the checkout experience according to risk—without slowing fulfillment. This also suppo
Boomi Activates Data for the Enterprise9.3.2026 14:00:00 CET | Press release
New platform innovations activate contextual data to power production-scale enterprise AI, with a new European platform instance for localized control Boomi™, the data activation company, today announced new capabilities within the Boomi Enterprise Platform. Data activation brings data to life across systems and processes, delivering it with the right context and timing to power everything from AI to BI. The Boomi Enterprise Platform, the foundation that puts data in motion, now adds new semantic context to help AI agents operate on grounded business realities, expands governed SAP data movement with change data capture, enhances transparency and oversight across agentic workflows, and introduces a dedicated European platform instance for localized data control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260309682526/en/ Boomi Activates Data for the Enterprise “Last year, Boomi helped enterprises move from experimentatio
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