Sebia Receives U.S. FDA Clearance for the FLC Kappa & Lambda Assays
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/
Contact information
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
FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia23.12.2025 18:07:00 CET | Press Release
The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States. Deseyne® delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia’s patented hyper-refractive central zone, engineered to precisely redirect light in a controlled manner. The result is a clear clinical advantage over the only other available contact lens option for presbyopia, multifocal lenses, which rely on multiple optical zones and often require prolonged visual and cognitive adaptation. “We are proud to offer the first contact lens solution for the world’s aging population th
Aramco Awards SLB Long-Term Contract to Support Kingdom’s Unconventional Gas Production Growth23.12.2025 14:58:00 CET | Press Release
Global technology company SLB (NYSE: SLB) has been awarded a five-year contract by Aramco to provide stimulation services for its unconventional gas fields. This award is part of a broader multi-billion contract, supporting one of the largest unconventional gas development programs globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251223074948/en/ The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources. The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources — a cornerstone of the Kingdom’s strategy to diversify its energy portfolio and support the global energy transition. “This agreement is an important step forward in Aramco’s effor
Tabelog, Japan's Largest (*1) Restaurant Search and Reservation Service, Launches Multilingual App for International Visitors23.12.2025 14:00:00 CET | Press Release
Tabelog (https://tabelog.com/en/), Japan's largest restaurant search and reservation service operated by Kakaku.com, Inc., launched its multilingual smartphone application (iOS/Android) for international travelers on Monday, November 17, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251221963753/en/ The Tabelog Multilingual App for International Travelers — Japan's Largest Restaurant Search and Reservation Service With approximately 100 million monthly users(*3), Tabelog is Japan's premier service widely used by Japanese locals for daily restaurant discovery. Its database is unrivaled domestically, featuring information on approximately 890,000 establishments nationwide and over 85 million reviews and photos(*4). Unlike global map services or travel sites, Tabelog is built on "authentic ratings and reviews from local Japanese users," enabling travelers to discover truly exceptional restaurants beloved by locals — not
BeOne Medicines to Present at the 44th Annual J.P. Morgan Healthcare Conference23.12.2025 12:01:00 CET | Press Release
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will participate in the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, with a presentation at 7:30 am PST. Live webcasts of these events can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com, https://hkexir.beonemedicines.com, https://sseir.beonemedicines.com. Archived replays will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company based in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to
I-care Becomes a Unicorn23.12.2025 10:45:00 CET | Press Release
I-care announces the completion of a €20 million fundraising and refinancing operation, carried out as a round reserved for existing shareholders and employees. Based on this operation, the group's valuation reaches €1 billion, making I-care a unicorn. "Becoming a unicorn is a symbolic milestone. To achieve this, we chose to invest before reaping the rewards: we bet on AI when few believed in it, we prioritized R&D, and we built our own production unit. These choices were sometimes difficult, but they were essential to staying ahead of the game. Today, our results confirm that this strategy was the right one," explains Fabrice Brion, CEO of I-care. This fundraising round is the first step in a three-phase development plan. Following the “Eau Rouge” operation in 2022, which enabled I-care to become the world leader in predictive maintenance, the company has now set itself a clear objective: to accelerate its growth in order to increase its market share. The second phase of this plan wil
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