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www.fdanews.com/articles/207138-siemens-healthineers-multiple-sclerosis-test-designated-an-fda-breakthrough-device

Siemens Healthineers Multiple Sclerosis Test Designated an FDA Breakthrough Device

March 28, 2022

Siemens Healthineers’ ADVIA Centaur serum neurofilament light chain (sNfL) assay has received the FDA’s Breakthrough Device designation.

The assay is intended for use as an aid in identifying adult patients with relapsing multiple sclerosis who are at lower risk versus higher risk of multiple sclerosis disease activity.

Developed in collaboration with Novartis Pharma, the assay measures neurofilament light in human serum and plasma, a biomarker for nerve cell injury.

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