Neurofilament Light Chain Blood Test for Multiple Sclerosis Developed by Siemens Healthineers is First of its Kind to Achieve CE Mark

Not for publication in the U.S.

• New blood test developed in collaboration with Novartis aims to improve management of MS 
• Identifying MS-related neuronal injury earlier would support better management of the disease 
• NfL, as a blood-based biomarker, shows potential in supporting other neurological diseases 

Siemens Healthineers is closer to making a blood test for multiple sclerosis (MS) disease management available. The company has achieved CE mark¹ for its Neurofilament Light Chain (NfL) assay for use on the Atellica IM Analyzer and the ADVIA Centaur XP/XPT Systems², developed in collaboration with Novartis Pharma AG, and plans to launch the assay in Europe later this year. 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.³ 

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.⁴ 

"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. 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." 

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. 

Blood-based biomarkers such as NfL are expanding the understanding of neurological diseases. They also are expected to rapidly change the practice of neurology.⁵ Siemens Healthineers is well-positioned with the Atellica Solution to support neurological diseases with tests that can be run on widely accessible laboratory platforms, making these types of tests available to more physicians for their patients.