FDA Grants Breakthrough Device Designation for Siemens Healthineers’ sNfL Test

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Siemens Healthineers’ ADVIA Centaur serum Neurofilament Light Chain (sNfL) assay, developed in collaboration with Novartis Pharma AG.
 
The ADVIA Centaur sNFL assay^1,2 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 (MS) disease activity.
 
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.³ MS is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves, and spinal cord.⁴ A February 2019 Neurology publication funded by the National Multiple Sclerosis Society estimated nearly 1 million people in the United States have MS. By 2025, an estimated $23 billion will be spent annually on treating the disease.⁵
 
“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.”
 
References:
^1. This product is under development and not commercially available. Its future availability cannot be ensured.
^2. The ADVIA Centaur serum Neurofilament Light Chain (sNfL) assay is for in vitro diagnostic use in the quantitative measurement of Neurofilament Light Chain (sNfL) in human serum and plasma (lithium heparin, EDTA) using the ADVIA Centaur system. The ADVIA Centaur sNFL assay, 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 Relapsing Multiple Sclerosis (RMS), who are at lower versus higher risk of MS disease activity, as defined by new or enlarging T2 Magnetic Resonance Imaging (MRI) lesions, within a 2 year period.
^3. Khalil et al.: Neurofilaments as biomarkers in neurological disorders. Nature Reviews; Neurology. 2018; 14: 577–589.
^4. Wallin et al. Neurology. 2019 Mar 5; 92(10): e1029–e1040
^5. iHealthcareAnalyst. “Global Multiple Sclerosis Drugs Market $23.5 Billion by 2025.” Published January 14, 2020.