 blood test for multiple sclerosis (MS) that has now received the CE mark.){kind=link}
Siemens Healthineers, in collaboration with Novartis, has developed a pioneering Neurofilament Light Chain (NfL) blood test for multiple sclerosis (MS) that has now received the CE mark. This innovative assay, designed for use on the Atellica IM Analyzer and the ADVIA Centaur XP/XPT Systems, is set to launch in Europe later this year. The test is poised to significantly enhance the management of MS by enabling earlier identification of neuronal injury in patients with Relapsing Multiple Sclerosis (RMS).
This novel blood test aims to complement existing clinical, imaging, and laboratory findings to better predict the risk of MS disease activity. By identifying early signs of MS-related neuronal injury, the test could assist neurologists in preventing relapses and mitigating the progression of the disease.
MS, a chronic autoimmune and neurodegenerative disease, affects approximately 2.8 million people globally, although the actual number is likely higher due to underdiagnosis in underserved regions. Axonal loss, which leads to irreversible neurological damage and disability, is a significant factor in MS.
Dr. Dennis Gilbert, Head of Research, Development, and Innovation for Diagnostics at Siemens Healthineers, emphasized the importance of this advancement: “While treatments exist to reduce relapse frequency in MS, there has been a critical need for an accessible, cost-effective, and accurate blood-based test to detect early neuronal injury and disease activity. Neurofilament light chain (NfL) has emerged as a key biomarker for nerve cell damage, and having a test that measures this protein crossing the blood-brain barrier could be a game-changer for MS patients.”
The NfL assay is intended for in vitro diagnostic use, measuring NfL in human serum and plasma. It aims to aid in identifying adult RMS patients at higher risk of disease activity, defined by new or enlarging T2 magnetic resonance imaging lesions within a two-year period.
Blood-based biomarkers like NfL are expanding the understanding of neurological diseases and are expected to transform neurology practices. Siemens Healthineers is well-equipped to support this shift with the Atellica Solution, making these crucial tests more accessible to physicians and their patients.