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
Laserfiche Earns 5-Star Rating in the 2026 CRN® Partner Program Guide11.3.2026 15:00:00 CET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — has been honored by CRN®, a brand of The Channel Company, with a 5-Star Award in the 2026 CRN Partner Program Guide. This annual guide is an essential resource for partners seeking vendor partner programs that match their business goals and deliver high partner value. As organizations navigate growing pressure to increase productivity and respond to regulatory change, Laserfiche’s AI-powered document management solutions enable users to transform operations and achieve meaningful business results at scale. Partners that innovate with Laserfiche solutions have the opportunity to grow profits through the Laserfiche Partner Program, which equips them with the tools and resources needed to deliver customer success. Laserfiche’s partner ecosystem drives sustainable growth, delivers differentiated solutions and maximizes opportunities for both partners and their customers. Laserfiche provides comprehensive AI and clou
I-Pulse Launches iTerra Pulsed Power Solution for Weed Control Without Chemicals11.3.2026 14:30:00 CET | Press release
iTerra is developing a non-chemical alternative to herbicidesiTerra combines high pulsed power and AI for weed control to support healthier crops I-Pulse Co-Founder, Chairman, and CEO Robert Friedland, I-Pulse Co-Founder and Chief Technology Officer, Laurent Frescaline, and iTerra CEO, Romain Leray, are pleased to announce the launch of iTerra, an agricultural technology subsidiary dedicated to non-chemical weed control within I-Pulse, the world leader in pulsed power technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311080724/en/ iTerra leverages I-Pulse’s proprietary high pulsed power technology to eliminate weeds at the root without harming crops, disrupting soil microbiology, or leaving chemical residues. Using AI-driven detection with accuracy rates of up to 95% in early trials, the system targets each weed individually with controlled, high-energy pulses lasting just five milliseconds. The treated weeds r
Canva Introduces Magic Layers, Turning Static AI Outputs Into Editable Designs11.3.2026 14:00:00 CET | Press release
Breakthrough in Canva Design Model now unlocks ability to transform flat content and images into layered and fully editable designs Canva, the world's leading all-in-one visual communication platform, today unveiled Magic Layers, a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311951174/en/ Magic Layers is a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. Generative AI has triggered a flood of visual content, but most of it remains locked in static image files. Even small changes can require starting over, with reprompts that can unintentionally alter the entire design. Powered by years of internal research and Canva’s growing investment in its AI development arm, Magic Layers ushers in a new era of editable
Xsolla Releases New Industry Report Identifying the Biggest Opportunities for the Future of Video Games for Developers11.3.2026 14:00:00 CET | Press release
The Xsolla Report Reveals How Studios Are Unlocking New Revenue, Reaching Global Audiences, and Building Durable Competitive Advantages Xsolla, a leading global video game commerce company, today released the latest edition of The Xsolla Report, timed to coincide with this week's activations and collaborations in San Francisco. This edition provides insights from working with thousands of studios to map out where the industry’s biggest opportunities are emerging. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311021020/en/ Graphic: Xsolla The gaming industry remains extraordinarily vibrant, and the playbook for success is changing. Studios that are adapting their commercial strategies, embracing direct-to-player commerce, expanding into high-growth global markets, and leveraging AI to sharpen operations are pulling ahead and building businesses designed to thrive for years to come. "The economics of game development have
Adtran plays key role in OIF’s OFC 2026 interoperability demo with FSP 3000 OLS, ZR+ coherent plugs and domain controller11.3.2026 14:00:00 CET | Press release
News summary: Live OIF demo brings together 40 companies to highlight real‑world multi‑vendor operation across open optical networks Showcase demonstrates interoperable 100G, 400G and 800G ZR+ transport over open line systems with multi-domain control Adtran’s ZR+ pluggables feature across both the OIF demo and plugfest, highlighting their role in open, multi-vendor deployments at scale Adtran today announced it’s playing a key role in the OIF’s multi-vendor interoperability demo at OFC 2026. The showcase brings together 40 member companies, highlighting real‑world operation across open optical networks. It validates multi‑vendor 100Gbit/s, 400Gbit/s and 800Gbit/s ZR+ coherent pluggable transceivers operating over open line systems. Featuring Adtran’s FSP 3000 OLS, coherent ZR+ pluggable optics and Mosaic Network Controller, the setup extends previous years’ configurations to include C‑ and L‑band operation and multi‑layer domain control. Adtran’s 800Gbit/s ZR+ pluggables also feature
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