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
TreviPay Partners with Dynatos to Add e-Invoicing Capabilities to its B2B Payments Infrastructure15.9.2026 07:00:00 CEST | Press release
The partnership brings e-invoicing technology and compliance expertise into TreviPay’s B2B payments infrastructure as requirements expand across Europe and other markets TreviPay, a global B2B payments infrastructure partner, today announced a partnership with Dynatos to expand e-invoicing capabilities for TreviPay clients operating across Europe and other markets. Through the partnership, Dynatos Routty Cloud proposition will provide embedded e-invoicing technology and compliance support, helping TreviPay clients exchange invoices across different formats, networks and country requirements in Europe and other global markets. E-invoicing requirements continue to expand across Europe and other global markets, adding complexity for businesses managing invoices across more than 60 countries with mandates announced or already in place. At the same time, invoicing has become an increasingly important part of the B2B buyer experience. TreviPay research found 68% of B2B buyers are more likely
Meiji Group to Showcase Japanese-Quality CMO/CDMO Services and a Global Manufacturing Network at CPHI Milan 202615.9.2026 07:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (HQ: Chuo-ku, Tokyo; President and CEO: Toshiaki Nagasato) will debut as the Meiji Group’s Pharmaceutical Segment at CPHI Milan 2026, at Fiera Milano, Milan, Italy, October 6–8, 2026. At the exhibition, the Meiji Group’s Pharmaceuticals Segment will showcase 80 years of expertise in Japanese standard quality control, manufacturing, and supply network from Japan to Europe, India, and Southeast Asia. It will also highlight group-wide contract manufacturing, from development to supply, tailored to customer needs. Through the exhibition, Meiji Seika Pharma aims to raise global awareness of the Meiji Group’s Pharmaceutical Segment, its brands, capabilities, production capacity, and contract manufacturing services, and to forge new global partnerships to expand its CMO/CDMO business. “CPHI Milan 2026” Exhibition Overview Exhibition Name: CPHI Milan 2026 Dates: October 6 (Tue) – 8 (Thu), 2026 Venue: Fiera Milano (Milan, Italy) Exhibition Area: CMO Area Booth Numbe
Signaloid joins Open Chiplet Atlas Alliance andAnnounces Plans to Make Its UxHw ASICs Available via OCA Ecosystem15.9.2026 06:00:00 CEST | Press release
British compute hardware company Signaloid joins Open Chiplet Atlas (OCA) and plans to bring its distribution-extended compute hardware (UxHw) compute acceleration technology to the OCA ecosystem.UxHw technology speeds up compute-intensive stochastic workloads in AI, science and engineering simulations, robotics, and quantitative finance. British compute hardware company Signaloid has joined the Open Chiplet Atlas (OCA) and announced plans to make its UxHw® compute acceleration technology available as chiplets within the OCA ecosystem. The UxHw technology targets AI and simulation workloads that rely on stochastic methods, including quantitative finance, reinforcement learning, engineering simulations, and world models. The announcement follows Signaloid’s recent tapeout of a UxHw ASIC for robotics and physical AI in an ultra-low-power TSMC process. “The Open Chiplet Atlas (OCA) increases innovation in chip design by defining an open architecture for multi-vendor chiplet interoperabili
Rimini Street and Datacom Announce Strategic Partnership to Accelerate AI Adoption and Drive IT Optimisation Across ANZ14.9.2026 22:00:00 CEST | Press release
Collaboration delivers expert third-party support for Oracle and SAP, keeping systems secure, compliant and stable for immediate Agentic AI ERP innovation while freeing up capital for growth and profitability Rimini Street Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle and SAP software, today announced a strategic partnership with Datacom, one of Australasia’s largest homegrown technology services and solutions providers. The reseller agreement will see Datacom offer Rimini Support™ for Oracle and SAP software to its public and private sector customers across Australia and New Zealand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914070894/en/ Rimini Street and Datacom Announce Strategic Partnership to Accelerate AI Adoption and Drive IT Optimisation Across ANZ This collaboration brings together Rimini Street's third-party software support, t
Lattice to Showcase Next Gen Automotive Sensing Innovations at AutoSens Europe 202614.9.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its exhibition plan for the upcoming AutoSens Europe 2026, taking place on Sept. 22 – 24, 2026, in Barcelona, Spain. As part of the event, Lattice will deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are enabling next-generation automotive sensing, ADAS, and in-vehicle networking applications. Who: Lattice Semiconductor What / When (GMT+2): Sept. 22 – 24, 2026 Lattice Demo Showcase at Booth #215 from local dimming, camera monitoring system, sensor security, and more. Presentation (Sept. 23 at 2:30 p.m., Room 5) “Efficient 360° threat detection for parked vehicles – A distributed, event-driven approach” Where: La Farga de L’Hospitalet, Barcelona, Spain AutoSens Europe is the automotive industry's premier conference and exhibition for perception systems, ADAS, and autonomous vehicle technology. Bringing together over 1,000 en
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