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Siemens gets breakthrough device designation for sNfL assay

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June 2022—Siemens Healthineers announced the FDA has granted breakthrough device designation for the Advia Centaur serum neurofilament light chain (sNfL) assay, developed in collaboration with Novartis Pharma. The assay quantitatively measures NfL in human serum and plasma and is intended to be used in conjunction with clinical, imaging, and laboratory findings as an aid in identifying adult patients with relapsing multiple sclerosis who are at lower risk, versus higher risk, of multiple sclerosis disease activity.

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