The company’s solution claims to offer a simplified workflow and rapid outcomes. Credit: cawee / Shutterstock.

该公司解决方案声称提供简化的流程和快速的结果。图片来源：cawee / Shutterstock。

AliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray.

AliveDx 已提交 510(k) 上市前通知，寻求美国食品药品监督管理局 (FDA) 对其 MosaiQ AiPlex 结缔组织疾病 (CTDplus) 微阵列的批准。

This multiplex assay is tailored to improve both the accuracy and speed of diagnosing systemic CTD, as well as the streamlining of lab workflows.

该多重检测方法旨在提高诊断系统性CTD的准确性和速度，并简化实验室工作流程。

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According to the company, systemic autoimmune rheumatic conditions such as scleroderma, rheumatoid arthritis and idiopathic inflammatory myopathies affect millions of individuals globally and are often related to the production of autoantibodies.

据该公司称，系统性自身免疫风湿病如硬皮病、类风湿性关节炎和特发性炎症性肌病等影响着全球数百万人，并且常与自身抗体的产生有关。

AliveDx’s MosaiQ solution claims to offer a simplified workflow and rapid outcomes by integrating several relevant markers into one test.

AliveDx的MosaiQ解决方案声称通过将多个相关指标整合到一个测试中，提供了简化的流程和快速的结果。

This approach not only provides “actionable insights” for individual care but also minimises hands-on time and reduces consumable use.

这种方法不仅为个人护理提供了“可操作的见解”，而且还最大限度地减少了手动操作时间并减少了耗材的使用。

Claiming to detect up to 1,275 disease markers an hour, the assay facilitates a syndromic approach to assess rheumatoid arthritis and systemic CTD, aiding healthcare providers in their diagnostic processes.

该检测方法声称每小时可检测多达 1,275 种疾病标志物，有助于采用综合征方法评估类风湿性关节炎和系统性结缔组织病 (CTD)，帮助医疗保健提供者进行诊断。

Included in the microarray are 15 markers for every patient panel, encompassing most of the autoantibodies recommended by the American College of Rheumatology and the European Alliance of Associations for Rheumatology clinical guidelines.

微阵列包含每个患者样本的15个标记物，涵盖了美国风湿病学会和欧洲风湿病协会联盟临床指南推荐的大多数自身抗体。

The assay can concurrently detect autoantibodies to a range of markers, including dense fine speckled protein of 70 kD (DFS70)/lens epithelium-derived growth factor (LEDGF), cyclic citrullinated peptide (CCP), and double-stranded DNA (dsDNA), among others.

该检测方法可以同时检测针对多种标志物的自身抗体，包括70千道尔顿的致密细小斑点蛋白（DFS70）/晶状体上皮衍生生长因子（LEDGF）、环瓜氨酸肽（CCP）和双链DNA（dsDNA）等。

AliveDx CEO Manuel Méndez said: “With autoimmune disease diagnoses often taking more than four years, there is a critical need for a multiplexed and syndromic approach to accelerate the process.

AliveDx首席执行官曼努埃尔·门德斯表示：“由于自身免疫性疾病的诊断通常需要四年以上的时间，因此迫切需要一种多重和综合征的方法来加速这一过程。"

“The MosaiQ AiPlex CTDplus microarray addresses this challenge by enabling early disease detection and supporting more targeted, effective treatments—ultimately providing much-needed relief to patients.

“MosaiQ AiPlex CTDplus 微阵列通过实现疾病的早期检测并支持更有针对性、更有效的治疗，解决了这一挑战，最终为患者提供亟需的缓解。”

“With our MosaiQ AiPlex Celiac Disease microarray already under review by the FDA, today’s submission brings us a significant step closer to delivering clinical and economical value to customers in the US.”

“我们的MosaiQ AiPlex乳糜泻微阵列已经在FDA审查中，今天的提交使我们向为美国客户提供临床和经济价值迈出了重要的一步。”

The assay received

收到的化验

in vitro diagnostic device regulation (IVDR)-CE mark

体外诊断设备法规 (IVDR) - CE 标志

certification in February 2025.

2025年2月的认证。

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