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
Andersen Consulting tilføjer samarbejdspartneren Milestone Technologies19.3.2026 19:02:00 CET | Pressemeddelelse
Andersen Consulting fortsætter med at styrke sin platform for digital transformation med tilføjelsen af samarbejdspartneren Milestone Technologies, der er en veletableret global leverandør af it-services og digitale løsninger med base i USA. Milestone Technologies blev grundlagt i 1997 og leverer omfattende teknologi- og outsourcingløsninger, der spænder over digitale arbejdspladstjenester, cloud- og infrastrukturstyring, data, AI og automatisering, apps og digital engineering, business process outsourcing samt implementering af platforme som ServiceNow og Salesforce. Med hovedkontor i Fremont, Californien, opererer Milestone i 35 lande på globalt plan og samarbejder med nogle af verdens største virksomheder. Virksomhedens integrerede leveringsmodel gør det muligt for kunder at transformere deres it-drift, øge serviceeffektiviteten og skalere teknologiske økosystemer gnidningsfrit over hele verden. "Milestone Technologies er en medarbejderfokuseret organisation, der leverer målbare for
Klarna Card reaches 5 million active customers19.3.2026 15:31:00 CET | Press release
Klarna, the global digital bank and payments provider, today announced that the Klarna Card has reached 5 million active customers globally, underscoring rapid adoption as consumers shift towards new forms of payment which provide more control over day-to-day money management. The card draws from the customer's own funds for everyday spending, with the option to spread the cost of a specific purchase, like a large appliance or a flight, when it makes sense to do so. The result is a card that offers genuine spending control without the long-term debt obligations that come with traditional credit cards. The card’s growth is reinforced by Klarna’s membership program. The program offers premium perks such as airport lounge access, travel insurance, and lifestyle subscriptions — without requiring users to take on debt, meet spending thresholds, or revolve balances. By separating everyday spending from rewards, Klarna is challenging the strings-attached model legacy banks have long relied on
Stonebranch Releases 2026 Global State of IT Automation Report, Revealing Orchestration as the Missing Link for AI Adoption and Trust19.3.2026 14:30:00 CET | Press release
New research shows hybrid IT orchestration, automation-as-a-service, and WLA investments are accelerating as AI workflow deployment scales across the enterprise. Stonebranch, a leading provider of service orchestration and automation solutions, today released its annual 2026 Global State of IT Automation Report, the company’s most comprehensive research study to date. Based on responses from 402 IT automation professionals spanning C-suite executives to individual contributors across North America, EMEA, Latin America, and APAC, the report provides a detailed, data-driven portrait of how enterprises are investing in, deploying, and deriving value from IT automation in 2026. “This year’s findings highlight an important shift in how organizations approach automation,” said Giuseppe Damiani, CEO of Stonebranch. “Organizations are now building automation as strategic infrastructure — a governed, scalable foundation that spans hybrid environments, operationalizes AI, and delivers automation
Perma-Pipe Accelerates Growth with New U.S. Northeast Facility Investment to serve Artificial Intelligence Data Center customers, Provides Middle East Operations’ Update and Concludes the Board’s Review of Strategic Alternatives19.3.2026 14:00:00 CET | Press release
Perma-Pipe International Holdings, Inc. (the “Company”) today announced a strategic expansion initiative focused on accelerating growth through entry into the high-demand U.S. Northeast region. The Company is positioning itself to capitalize on the rapidly expanding Artificial Intelligence (“AI”)-driven data center market in both the United States and international markets while continuing to reinforce its leadership in critical infrastructure solutions. As part of this growth strategy, Perma-Pipe will prioritize investments aimed at expanding its presence in the rapidly evolving AI data center sector. The initiative reflects the Company’s long-term commitment to supporting next-generation technology infrastructure and strengthening its position in the global energy, industrial, and infrastructure markets. Expansion in the U.S. Northeast President & Chief Executive Officer, Saleh Sagr said, “We are excited to announce the expansion of our operations with a new facility in the Northeast
Armis Launches First-of-Its-Kind Benchmark Report Warning of Critical Security Gaps in AI-Native Development19.3.2026 13:00:00 CET | Press release
Research reveals 100% of leading generative AI models fail to generate secure code for critical development scenarios Armis, the cyber exposure management & security company, is warning that the rapid enterprise adoption of AI-native development is outpacing critical security safeguards, leaving organizations exposed to systemic vulnerabilities. New research from Armis Labs’ Trusted Vibing Benchmark Report, which evaluates 18 leading generative AI models across 31 test scenarios, reveals a 100% failure rate in generating secure code. These vulnerabilities are most prevalent in high-risk areas like memory buffer overflows, design file uploads and authentication systems. Therefore, organizations should immediately implement AI-native application security controls to reduce risk. “The era of vibe coding is here, but speed should not come at the cost of security,” said Nadir Izrael, CTO and Co-Founder of Armis. “Our research finds that the worst offenders are the same ones selling security
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