Neurofilament light chain blood test for multiple sclerosis achieves CE mark

Siemens Healthineers is closer to making a blood test for multiple sclerosis (MS) disease management available, with plans to launch the assay in Europe later this year. The company has achieved a CE mark (CE 0197) 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. 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 the 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.

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. 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.

This product is not yet commercially available in all countries. Not for sale in the USA. Future availability cannot be guaranteed.

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