Siemens Healthineers announces collaboration agreement for assay development with focus on MS

Sept. 22, 2020

Siemens Healthineers announced a master collaboration agreement with Novartis Pharma AG to design, develop, and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline, according to a press release. The initial program assists the development of a serum NfL immunoassay to support Novartis’ MS and other neuroscience programs.

NfL is a highly specific 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.

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. The Multiple Sclerosis Foundation estimates that more than 2.5 million people in the world and more than 400,000 people in the United States have MS. By 2025, an estimated $23 billion will be spent annually on treating the disease.

The global burden of chronic neurological diseases continues to increase, and a 2016 study concluded that neurology disorders are the second leading cause of death and leading cause of DALYs (disability-adjusted life-year). Serum NfL would expand Siemens Healthineers Laboratory Diagnostics Neurology test menu, which also targets AB42 and Tau assays for the clinical diagnosis of Alzheimer’s disease. The Siemens Healthineers AB42 and Tau assays were recently granted FDA Breakthrough Device Designation for expedited reviews.

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