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Siemens Healthineers secures CE mark for novel MS blood test

Siemens Healthineers has announced the CE marking of its Neurofilament Light Chain (NfL) assay for multiple sclerosis (MS) management. Developed in collaboration with Novartis Pharma AG, this blood test is designed for use on the Atellica IM Analyzer and the ADVIA Centaur XP/XPT Systems.

Potential impact on multiple sclerosis management

The NfL assay aims to aid in predicting the risk of disease activity in patients with Relapsing Multiple Sclerosis (RMS). By identifying MS-related neuronal injury earlier, the test could support neurologists in improving disease management and potentially preventing relapses and disease progression.

Technical specifications

The assay is intended for in vitro diagnostic use, quantitatively measuring NfL in both human serum and plasma. It is designed to be used in conjunction with clinical, imaging, and laboratory findings for adult patients aged 18-55 with RMS.

Dr Dennis Gilbert, Head of Research, Development, and Innovation for Diagnostics at Siemens Healthineers, noted: “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.”

Broader implications for neurology

Blood-based biomarkers like NfL are expanding the understanding of neurological diseases and are expected to significantly impact neurological practice. The availability of such tests on widely accessible laboratory platforms could increase their availability to physicians and patients.

Future prospects

While the NfL assay is not yet commercially available in all countries and is not for sale in the USA, Siemens Healthineers is positioned to support neurological disease testing with the Atellica Solution. This development aligns with the growing trend of blood-based biomarkers in neurology, potentially revolutionising diagnostics in conditions such as Alzheimer’s disease.

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