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
Budweiser Honors 40 Years of FIFA World Cup™ Legacy with Limited-Edition Collectible Pack and Nostalgia-Themed Platform7.4.2026 09:00:00 CEST | Press release
The iconic brand marks its return as the Official Beer Sponsor of FIFA World Cup™ with anniversary packaging, a global film, and creative billboard tributes to football’s greatest moments Today, Budweiser is celebrating 40 years as the Official Beer Sponsor of the FIFA World Cup™ with the launch of the largest limited-edition collectible pack ever – the Budweiser® FIFA World Cup™ Anniversary Pack* – bringing to life 11 bold design tributes to every tournament since 1986, and the centerpiece of a new nostalgia driven global platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407304059/en/ Budweiser® FIFA World Cup™ Anniversary Pack Throughout history, Budweiser has played an important role in some of football’s most unforgettable celebrations, from last-minute goals to trophy lifts seen around the world. These moments of “Budstalgia” [Budweiser + nostalgia] are the inspiration for the brand’s newest platform, brought
Toshiba’s Breakthrough Algorithm Harnesses Edge of Chaos to Dramatically Boost Performance of its Quantum‑Inspired Computer7.4.2026 09:00:00 CEST | Press release
~Approximately 100 times faster, will accelerate solutions for drug discovery, finance, and other complex problems~ Toshiba Corporation has developed a breakthrough algorithm that dramatically boosts the performance of the Simulated Bifurcation Machine (SBM), its proprietary quantum‑inspired combinatorial optimization computer. The new algorithm significantly improves the probability of obtaining an optimal solution or a known best solution within a limited number of trials—referred to as the success probability, a key benchmark for evaluating combinatorial optimization technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407918434/en/ Figure 1: Results demonstrating that the newly developed third‑generation SB algorithm can find the known best solution with nearly 100% probability at the edge of chaos for a fully connected 2,000‑spin Ising problem. The SBM is designed to solve large‑scale combinatorial optimizati
Ardabelle Reveals a €7 Trillion Challenge for Europe: Invest Now or Lose a Generation of Competitiveness7.4.2026 07:30:00 CEST | Press release
Europe is navigating a period of intense turbulence, where geopolitical crises, pressure on critical raw materials, and climate‑related shocks are reinforcing one another. This polycrisis is no longer cyclical: it is structurally reshaping the continent’s value chains and testing its industrial competitiveness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260406787383/en/ Europe's Choice: €27T Coordinated Growth or €20T Fragmented Decline by 2050 In this context, Ardabelle is releasing Greening the Arteries of Industry, a groundbreaking study that quantifies for the first time the economic gap between a Europe that endures and a Europe that invests. Conducted under the scientific supervision of economist Xavier Jaravel, this work represents the first attempt to model, in an integrated way, industrial resilience, ecological transition, and European competitiveness through 2035 - 2050. The study was presented under the high
Tigo Energy Launches New GO Optimized Energy Storage System in European Residential Market7.4.2026 06:00:00 CEST | Press release
Accepting orders for the GO Battery as part of the modular residential storage system with scalable capacity, seamless EI platform integration, and cold-weather reliability Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced availability of the Tigo GO Battery, a next-generation energy storage system and the latest addition to the Tigo GO optimized product line in Europe, joining the GO EV Charger and GO Junction for heat pump integration. The system delivers expandable energy storage capacity of up to 47.9kWh, faster installation via lightweight plug-and-play modules, and cold-weather operation down to -30°C. Installer preorders are currently available, with product shipping commencing in June 2026. The new GO Battery arrives as several European countries set new all-time single-day records for solar energy production, and global solar installations grew by 11% between 2024 and 2025. The Tigo GO
Saudi Fund for Development Signs USD 15 Million Agreement with the Republic of Palau to Drive Local Economic Growth6.4.2026 21:01:00 CEST | Press release
The Saudi Fund for Development (SFD) today signed a USD 15 million development loan agreement with the Republic of Palau, marking the Fund’s first-ever development partnership in the Pacific island nation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260406306007/en/ Saudi Fund for Development Signs USD 15 Million Agreement with the Republic of Palau to Drive Local Economic Growth (Photo: AETOSWire) The agreement was signed by H.E. Sultan Abdulrahman Al-Marshad, Chief Executive Officer of SFD, and H.E. Surangel S. Whipps Jr., President of the Republic of Palau during a ceremony in Palau’s capital, Ngerulmud. The USD 15 million development loan will be channeled through the National Development Bank of Palau. Designed to empower the local economy, the financing will support projects spearheaded by Palauan developers, businesses, and entrepreneurs. By aligning with Palau’s national priorities, the funds will catalyze high-im
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