June 2024- Siemens Healthineers is closer to making a blood test for Multiple Sclerosis (MS) disease management available. The company has achieved CE mark for its Neurofilament Light Chain (NfL) assay for use on the Atellica IM Analyzer and the ADVIA Centaur XP/XPT Systems, developed in collaboration with Novartis Pharma AG, and plans to launch the assay in Europe later this year.

2024年6月-西门子Healthineers即将推出多发性硬化症（MS）疾病管理的血液检测。该公司与诺华制药公司合作开发的用于Atellica IM分析仪和ADVIA Centaur XP/XPT系统的神经丝轻链（NfL）检测已获得CE标志，并计划今年晚些时候在欧洲推出该检测。

The test will be useful alongside other clinical, imaging, and laboratory findings to help predict the risk of MS disease activity in a patient with Relapsing Multiple Sclerosis (RMS). Identifying risk of MS-related neuronal injury earlier in patients with RMS would support neurologists and other physicians in better managing the disease, and potentially help to prevent relapses and worsening of disease..

该测试将与其他临床，影像学和实验室检查结果一起使用，以帮助预测复发性多发性硬化症（RMS）患者MS疾病活动的风险。早期识别RMS患者MS相关神经元损伤的风险将支持神经科医生和其他医生更好地管理疾病，并可能有助于防止疾病复发和恶化。。

MS is an autoimmune, inflammatory, and neurodegenerative disease in which axonal loss is the major cause of irreversible neurological damage leading to disability. Multiple sclerosis affects nearly 2.8 million people worldwide, although the number is anticipated to be higher as many people remain undiagnosed in underserved and remote communities without access to neurologists or adequate imaging equipment..

MS是一种自身免疫性，炎症性和神经退行性疾病，其中轴突丢失是导致残疾的不可逆神经损伤的主要原因。多发性硬化症影响着全世界近280万人，尽管预计这一数字会更高，因为在服务不足和偏远的社区，许多人仍未得到诊断，无法获得神经科医生或足够的成像设备。。

“While there is no cure for MS, treatments exist to decrease the frequency of relapses, thought to be associated with nerve cell damage and disease progression. What patients still need is an easily accessible, cost-effective, and accurate blood-based test that would indicate early signs of neuronal injury and disease activity,” said Dr.

“虽然MS无法治愈，但有治疗方法可以降低复发频率，这被认为与神经细胞损伤和疾病进展有关。患者仍然需要一种易于获得，具有成本效益且准确的血液检测方法，以指示神经元损伤和疾病活动的早期迹象，”Dr。

Dennis Gilbert, Head of Research, Development, and Innovation for Diagnostics at Siemens Healthineers. “Neurofilament light chain, or NfL, has emerged as a leading biomarker of nerve cell damage. Having access to a test that measures this protein capable of crossing the blood-brain barrier to support earlier prognostication of disease activity would be a critical scientific advancement for MS patients.”.

丹尼斯·吉尔伯特（DennisGilbert），西门子Healthineers诊断研究、开发和创新主管。“神经丝轻链或NfL已成为神经细胞损伤的主要生物标志物。获得一项测试，以测量这种能够穿过血脑屏障的蛋白质，以支持疾病活动的早期预测，将是MS患者的关键科学进步。”。

The NfL assay from Siemens Healthineers is for in vitro diagnostic use in the quantitative measurement of NfL in both human serum and plasma. The blood test, in conjunction with clinical, imaging, and laboratory findings, is intended to be used as an aid in identifying adult patients between 18-55 years of age with RMS, who are at a higher versus lower risk of MS disease activity, as defined by new or enlarging T2 magnetic resonance imaging lesions, within a two‑year period..

西门子Healthineers的NfL分析用于体外诊断，用于定量测量人血清和血浆中的NfL。血液测试与临床，影像学和实验室检查结果相结合，旨在帮助识别18-55岁的RMS成年患者，这些患者在两年内具有较高或较低的MS疾病活动风险，如新的或扩大的T2磁共振成像病变所定义。。