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
The LYCRA Company Announces Strategic Partnership on Renewable LYCRA® Fiber2.4.2026 15:00:00 CEST | Press release
Agreement with Texhong Advances Sustainable Fiber Applications The LYCRA Company, a global leader in innovative and sustainable fiber solutions for the apparel and personal care industries, today announced the signing of a strategic partnership agreement with Texhong International Group Limited (“Texhong”), one of the world’s largest suppliers of core-spun cotton textiles. Under the agreement, Texhong will exclusively partner with The LYCRA Company to bring Renewable LYCRA® fiber made with 30 percent plant-based content* to China’s core-spun yarn sector. This collaboration aims to accelerate the adoption of bio-derived spandex across the global apparel and textile industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402505834/en/ The LYCRA Company announced a strategic partnership with Texhong International Group for renewable LYCRA® fiber. Pictured at the signing ceremony held in Shanghai (left to right): Jason Wang,
Brightfin Unifies Brand Following Proven Optics Merger, Delivering a New Standard for Technology Cost Optimization2.4.2026 15:00:00 CEST | Press release
New identity reflects expanded vision to help CIOs “See Clearly. Spend Better.” Brightfin today announced that, following its merger with Proven Optics, the combined company will operate under a single brand: Brightfin. The unified company brings together deep expertise in Technology Expense Management (TEM) and IT Financial Management (ITFM) to help organizations better understand, manage, and reduce total technology spend. Technology spending will exceed $6 Trillion this year, and for most organizations, it remains one of the least understood. CIOs can tell you what they’re spending. Far fewer can tell you whether it’s working. “Over the past several months, we’ve brought these two businesses together around a shared purpose: help enterprise businesses better understand and optimize their technology spend,” said Joel Martins, CEO of Brightfin. “What we are seeing now is a shift. Visibility alone isn’t enough. Teams need to be able to act, tied to real financial outcomes. See Clearly.
Lenovo 360 Framework Evolves with Simplified Tiers, Services Growth Pathways, and New Technical Community2.4.2026 15:00:00 CEST | Press release
New enhancements to Lenovo 360 make growth more intuitive, profitable, and collaborative for Lenovo partners Lenovo today announced new enhancements to its global channel framework, Lenovo 360, building on the success of its channel-centric model to further simplify and accelerate partner growth. Lenovo 360 has become the foundation for how Lenovo enables, connects with, and grows alongside its global partner ecosystem. These latest updates reflect Lenovo’s continued commitment to evolving the partner experience and creating more intuitive, scalable paths to growth. "The channel is central to how we do business,” said Pascal Bourguet, Chief Sales Strategy & Channels Officer at Lenovo. “It’s how we scale, how we innovate, and how we grow together. With these latest enhancements to Lenovo 360, we’re making it simpler, more predictable, and more rewarding for partners to build their business with us. From services-led growth to new technical communities and streamlined tiering, we’re focu
IFF Launches PureStrong™, a Probiotic Made Specifically for Dogs2.4.2026 14:15:00 CEST | Press release
IFF (NYSE: IFF)—a global leader in flavors, fragrances, food ingredients and health & biosciences—is introducing PureStrong™, a new probiotic developed exclusively for canine digestive health. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401736960/en/ IFF introduces PureStrong™, a probiotic made specifically for dogs. Today, many people consider their pet dogs part of the family. This shift is fueling rapid growth in the $3.2 billion U.S. pet supplement market. With nearly half of U.S. pet owners having purchased or considering probiotics for their dogs, PureStrong™ sets a new standard: pet‑first science built specifically for canine biology. “PureStrong™ is sourced directly from the microbiome of healthy canines and designed to support how dogs actually live—how they eat, travel, age and adapt to change,” said Allyson Fish, senior vice president of health sciences for IFF. “That’s how IFF leads pet wellness: science-dr
Adtran extends 400G to the edge with new Terabit routing solution2.4.2026 14:00:00 CEST | Press release
News summary: Operators face rising edge capacity demands as 100G becomes standard across access, aggregation and mobile backhaul Adtran’s new Terabit-class edge routers deliver high-capacity in compact, cabinet-ready platforms Open disaggregated architecture integrates routing, optics and software-driven management for simplicity, flexibility and control Adtran today extended its edge routing portfolio with new Terabit-class edge routers, featuring 400Gbit/s interfaces. These new devices give operators a practical, cost-effective way to scale capacity at the network edge without adding space, power or operational burden. Supported by a unified software foundation that simplifies deployment and operations across the portfolio, the solutions provide a consistent, future-ready environment for edge growth. With 100Gbit/s interfaces now widely deployed across fiber access, aggregation and mobile backhaul, operators need higher-capacity edge options that reduce cost, complexity and inventor
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