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
Manhattan Associates’ 2026 Unified Commerce Benchmark Reveals the High Price of Standing Still in Retail23.3.2026 13:30:00 CET | Press release
Leaders achieve up to 2X revenue growth, but only 7% of retailers are true unified commerce leaders Manhattan Associates Inc. (NASDAQ: MANH), today announced the findings of its 2026 Global Unified Commerce Benchmark for Specialty Retail, the industry’s most comprehensive assessment of how well retailers connect digital and physical experiences to drive growth, profitability and loyalty. Conducted by Incisiv, a leading retail research firm, the Benchmark is based on real-world purchases and returns. It analyzes more than 400 specialty retailers across EMEA, LATAM and North America on 330 capabilities spanning four key experience areas: Shopping, Checkout, Fulfillment, and Service. The 2026 Benchmark reveals that while the industry has made steady progress in unified commerce maturity since 2023 when it was first launched, only 7% of retailers have achieved true unified commerce leadership while 33% are still stuck in the Basic category. Leaders are translating connected, data‑driven ye
Starr Completes Acquisition of IQUW Group23.3.2026 13:00:00 CET | Press release
Creates a stronger, more diversified global specialty platform Starr, a global investment and insurance organization, today announced that it has completed its acquisition of IQUW Group, creating a broader, more diversified specialty (re)insurance platform with enhanced capabilities across the London market, Bermuda and UK retail motor. The combined Starr business now serves more clients and brokers in more specialist classes and market segments globally. With IQUW Group, Starr has strengthened its position in the London market and established its managing agency as the ninth-largest at Lloyd’s. Importantly, Starr will continue to operate with a strong emphasis on underwriting expertise and best-in-class broker and client experience and service. Clients and brokers will benefit from a broader product offering, quick decision-making, greater capital strength and expanded global reach. Starr’s reinsurance capability is also significantly enhanced following this transaction. IQUW Re Bermu
Biocytogen Announces Strategic Collaboration with Moonlight Bio to Advance Cell Therapies Using Library of Antibody Binders23.3.2026 13:00:00 CET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced a strategic collaboration with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced cell therapies. This partnership aims to develop cutting-edge cell therapies to address some of the most challenging and difficult-to-treat cancers. Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are thrilled to partner with Moonlight Bio, a pioneering leader in advanced cell therapies. This strategic collaboration leverages our proprietary off-the-shelf fully human antibody library to accelerate the development of cutting-edge cell therapies for difficult-to-treat cancers. It also demonstrates the versatility and broad applicability of Biocytogen’s antibody discovery platforms beyond traditional drug modalities. By combining our expertise,
Venture Global Launches First Advertising Campaign: “Unstoppable Energy”23.3.2026 11:30:00 CET | Press release
New ad campaign narrated by Academy Award winner Billy Bob Thornton will air nationally in the U.S. Today, Venture Global, Inc. (NYSE: VG) is launching its first national advertising campaign – “Unstoppable Energy”. The seven-figure, year-long campaign includes national and local broadcast television spots, as well as out-of-home, print, and digital ad placements. The company is proud to have Academy-Award winner Billy Bob Thornton as the campaign voiceover. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323692879/en/ “Venture Global is excited to unveil our very first national advertising campaign, featuring the accomplished Billy Bob Thornton as its voice,” said Venture Global CEO Mike Sabel. “The Unstoppable Energy campaign portrays the roll-up-your-sleeves tenacity and innovation that drives our company every day. We are proud to introduce the ethos and story of the Venture Global brand across the U.S. as we grow into
Venture Global and Vitol Announce New LNG Purchase Agreement23.3.2026 11:00:00 CET | Press release
Today, Venture Global, Inc. (NYSE: VG) and Vitol announced the execution of a new, binding agreement for the purchase of approximately 1.5 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for five years commencing in 2026, to be supplied from Venture Global’s portfolio. “Global demand for flexible, reliable U.S. LNG is rapidly growing, and Venture Global is proud to work with premier LNG trading companies like Vitol to provide this critical supply to the market,” said Venture Global CEO Mike Sabel. “Thanks to our innovative model, we have the ability to provide our customers with short, medium, and long-term LNG supply, and this agreement is another important step in diversifying the tenor of our LNG portfolio.” “Vitol is delighted to be working with Venture Global, a leading producer and supplier of LNG to world markets,” said Pablo Galante Escobar, Global Head of LNG at Vitol. “LNG is important to many economies worldwide. Through this transacti
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