Siemens sNfL Blood Test Predicts Risk of MS Disease Activity

Neurofilament Light Chain (NfL) is a biomarker for nerve cell injury measured in cerebral spinal fluid and blood. Blood NfL levels have been reported to change in a variety of serious neurological conditions, including MS, and have been related to disease activity and disability outcomes. Testing for level of NfL may provide valuable data in clinical trials for neurological disorders, including MS.

The ADVIA Centaur serum Neurofilament Light Chain (sNfL) assay, developed by Siemens Healthineers (Erlangen, Germany) in collaboration with Novartis Pharma AG (Basel, Switzerland), quantitatively measures NfL in human serum and plasma. It 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 MS disease activity. The blood-based NfL assay uses high-sensitivity Acridinium Ester (AE) technology designed to run on the Atellica Immunoassay system for serum, plasma, or CSF samples. The ADVIA Centaur sNfL assay has been granted Breakthrough Device Designation by U.S. Food and Drug Administration (FDA).

"Breakthrough Device Designation for the ADVIA Centaur sNfL assay is an important milestone in our collaboration with Novartis, bringing clinicians and people living with MS one-step closer to accessing a simple highly standardized blood test to prognosticate the risk of MS disease activity from the earliest stages of the disease," said Jennifer Zinn, Executive Vice President and Head of Diagnostics, North America, Siemens Healthineers. "We are committed to developing assays that will expand disease state care for patients, and can be performed on our expansive network of ADVIA Centaur and Atellica Solution immunoassay analyzers, as well as future analyzers.”

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