Siemens Healthineers announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ADVIA Centaur® serum Neurofilament Light Chain (sNfL) assay, developed in collaboration with Novartis Pharma AG. The ADVIA Centaur sNFL assay1,2 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.”
Siemens Healthineers offers a comprehensive menu of neuroradiology products and services. Additionally, the Siemens Healthcare Laboratory based in Berkeley, Calif. offers neurobiomarker testing services, including serum NfL, for biopharmaceutical company therapy development programs.
Learn more about Siemens Healthineers' neurobiomarker testing services here.
This product is under development and not commercially available. Its future availability cannot be ensured.
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.
Khalil et al.: Neurofilaments as biomarkers in neurological disorders. Nature Reviews; Neurology. 2018; 14: 577–589.
iHealthcareAnalyst. “Global Multiple Sclerosis Drugs Market $23.5 Billion by 2025.” Published January 14, 2020.
Contact for journalists
Kimberly Nissen, Siemens Healthineers
Phone: +1 610 241-2129
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) pioneers breakthroughs in healthcare. For everyone. Everywhere. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers and its regional companies is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, in-vivo diagnostics, and innovative cancer care. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care. In fiscal 2021, which ended on September 30, 2021, Siemens Healthineers, which has approximately 66,000 employees worldwide, generated revenue of €18.0 billion and adjusted EBIT of €3.1 billion. Further information is available at www.siemens-healthineers.com.