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临床蛋白质电泳设备和试剂供应商Sebia宣布FLC Kappa和Lambda检测获得美国FDA许可

Sebia Receives U.S. FDA Clearance for the FLC Kappa & Lambda Assays

businesswire | 2024-03-01 | 翻译由动脉网AI生成,点击反馈

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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.

Sebia是一家全球专业诊断公司,为肿瘤学、代谢性疾病、遗传性疾病和自身免疫性疾病的筛查和诊断提供创新解决方案,今天宣布已获得美国食品和药物管理局(FDA)510(k)FLC Kappa&Lambda检测许可。

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.

这些是首次从FDA获得510(k)的EIA测试,用于定量检测人血清标本中的κ和λ游离轻链,旨在帮助诊断和监测多发性骨髓瘤和免疫球蛋白轻链(AL-)淀粉样变性。

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).

Sebia FLC-kappa和FLC-lambda测定的临床评估显示与Freelite测定相当的临床敏感性(来自诊断为MM的患者的177个样品的96.6%)和改善的临床特异性(189个非骨髓瘤/非淀粉样变性受试者的85.1%)各种临床条件)。

These excellent performances have been notably highlighted in the Willrich et al publication released in 2022.

这些出色的表现在2022年发布的Willrich等人的出版物中得到了突出强调。

“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.

Sebia集团全球监管事务与质量副总裁Arnaud Collin说:“作为多发性骨髓瘤检测的全球领导者,Sebia通过这种新的解决方案扩大了其在美国的业务范围,该解决方案易于适应高通量处理的自动免疫分析仪器。ELISA格式克服了替代检测方法中常见的分析性能方面的主要挑战。”

ABOUT Sebia

关于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.

Sebia成立于1967年,是临床蛋白质电泳设备和试剂的世界领先供应商,该技术用于体外诊断测试。它的系统分析蛋白质,以筛选和监测各种疾病和状况;主要是肿瘤学(多发性骨髓瘤)和代谢紊乱,如糖尿病,血红蛋白病和罕见病。

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.

在2021年收购Orgentec,Corgenix,Arotec和2022年收购Zeus Scientific后,Sebia现在开发并销售创新的自身免疫诊断解决方案。

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).

该公司总部位于法国利斯,业务遍及120多个国家。Sebia由CVC Capital Partners、特提斯投资公司(Tethys Invest)和魁北克储蓄所(Caisse de Dépôt et Placement du Quebec,CDPQ)所有。

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