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
Horizon3 and Pax8 Expand Partnership to Bring Autonomous Security Testing to MSPs Across Europe16.10.2026 08:03:00 CEST | Press release
NodeZero® gives partners a repeatable way to identify exploitable attack paths, guide remediation, and prove fixes worked Horizon3, the AI-Native Proactive Security Company, today announced the expansion of its Pax8 partnership across Europe, bringing the NodeZero® Proactive Security Platform to the region’s managed service providers (MSPs) through the Pax8 Marketplace. The expansion enables partners to build recurring security services that help small and midsized businesses understand how attackers could compromise their environments, prioritize corrective actions, and verify remediation. Building on the companies’ North American marketplace launch, the European expansion makes autonomous offensive security testing accessible to more MSPs and the businesses they protect. Partners can use NodeZero to deliver initial assessments, support remediation engagements, and establish ongoing testing programs without conducting every penetration test manually. “MSPs are accountable for protecti
MSCI Launches a Consultation on a Proposal to Reclassify Indonesia from Emerging Market to Standalone Market Status15.10.2026 23:47:00 CEST | Press release
MSCI to consult on proposal to reclassify the MSCI Indonesia Indexes to Standalone Market status Existing freeze on Indonesian securities in MSCI Indexes to remain in place until further notice MSCI announced the launch of a consultation on a proposal to reclassify the MSCI Indonesia Indexes from Emerging Market to Standalone Market status. MSCI will announce its final decision by the end of June 2027 and may provide an interim update on market participant feedback during the consultation period. As part of the June 2026 Market Classification Review, MSCI reported that market participants had raised significant concerns regarding the investability of the Indonesian equity market, including persistent opacity in shareholding structures and suspected coordinated trading behavior. While the Indonesian authorities have announced reforms, including enhanced disclosure of shareholders with ownership above 1%, more granular investor classification disclosure, High Shareholding Concentration (
Nekome: Nazi Hunter Unmasks Hitler’s Hyenas in New Trailer Ahead of Steam Next Fest Demo15.10.2026 21:38:00 CEST | Press release
Free demo offers players the first chance to pick up the knife in ProbablyMonsters’ narrative-driven action game beginning on October 19 ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today unveiled a new trailer for Nekome: Nazi Hunterat the Galaxies Autumn Showcase, pulling back the curtain on the game’s villains, Hitler’s Hyenas. Alongside the new trailer, ProbablyMonsters announced that Nekome: Nazi Hunter will participate in October’s Steam Next Fest, giving players their first opportunity to experience this violent odyssey of revenge with a free PC demo available on Steam from October 19 through 26. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014661905/en/ “Nekome is Vano’s story: an exploration of a young Romani man who has had everything taken away from him, and who decides to pick up a knife and exact revenge on his family’s murderers,” said Jeronimo Barr
The Estée Lauder Companies Announces BEAUTY&YOU India 2026 Winners and Marks Five Years of Advancing Indian Beauty Entrepreneurship15.10.2026 17:58:00 CEST | Press release
In partnership with Startup India and Nykaa, the program recognizes five winners across in-market beauty brands, early-stage concepts, fragrance innovation, creative design, and women’s entrepreneurship. The Estée Lauder Companies, in partnership with Nykaa and Startup India, an initiative of the Department for Promotion of Industry and Internal Trade (DPIIT) within India’s Ministry of Commerce and Industry, announced the winners of BEAUTY&YOU India 2026, the country’s leading beauty entrepreneurship program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015612324/en/ (L to R) BEAUTY&YOU India 2026 Winners Ajaykumar Mehta, Shriya Rambhia, and Dheer Rambhia, Directors, Goyam Green Tech (BREAKTHROUGH), Nirja Bhatt, Founder & CEO, Laani (GROW), Khatija Shabana, CEO, and Syed Mohammad Fouzan, Director, Boldpurity (IMAGINE), Rinzing Choden Bhutia, Founder, Agapi Sikkim (Visionary Women’s Award), and Pankti Sheth, Founder & Cr
Body of Waves, a New Artwork Only at teamLab Planets TOKYO, Unveiled15.10.2026 17:00:00 CEST | Press release
The visitor experiences offered by “Existence in the Flow Creates Vortices” and “Waterfall of Ephemeral Crystals” have also been further expanded. teamLab Planets TOKYO (hereinafter referred to as “teamLab Planets”) has unveiled Body of Waves, a new artwork in which visitors enter a soft sculpture with their entire bodies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014474897/en/ teamLab, Body of Waves, 2026, from the series Soft Black Hole - Your Body Becomes a Space that Influences Another Body, 2016-© teamLab *Shot in real space. No AI or CGI. In addition, Existence in the Flow Creates Vortices—where vortices are created behind people as they climb against the flow—and Waterfall of Ephemeral Crystals—where shining particles cascade down to create a waterfall of light particles—have also evolved, further expanding the experience at teamLab Planets. New Artwork Body of Waves As you walk, your feet sink. This force is
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