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Siemens Healthineers Nabs CE Mark for MS Relapse Risk Test

NEW YORK – Siemens Healthineers said on Monday that the firm has received CE marking for a prognostic blood test that the firm plans to launch later this year in Europe to aid the management of multiple sclerosis.

The Neurofilament Light Chain (NfL) assay is used for the quantitative measurement of NfL in serum and plasma of patients between the ages of 18 and 55 years and is designed for use on Siemens' Atellica IM Analyzer and its Advia Centaur XP/XPT systems. Test results are used with clinical, imaging, and laboratory findings to identify a patient's risk of relapsing multiple sclerosis and higher MS disease activity.

Dennis Gilbert, head of diagnostics research, development, and innovation at Siemens, said in a statement that existing therapies for MS patients can decrease the frequency of relapses, which are 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," he said. "Neurofilament light chain, or NfL, has emerged as a leading biomarker of nerve cell damage."

Siemens said that it developed the assay in a collaboration with Novartis Pharma.