Siemens Healthineers, Novartis Partner to Develop NfL Diagnostic Test

The development of a diagnostic test using neurofilament light chain (NfL) — a biomarker for nerve cell damage — for people with multiple sclerosis (MS) will be part of a collaboration program between Siemens Healthineers and Novartis.

The goal of this new collaboration is to design, develop, and globally distribute diagnostic tests for MS and other neurological diseases. The initial focus will be to develop NfL immunoassays, highly specific tests that can be used to detect or quantify the biomarker in the blood.

“We are looking forward to our collaboration with Novartis as it promises to yield innovative diagnostic solutions to address critical unmet clinical needs,” Deepak Nath, PhD, president of Laboratory Diagnostics at Siemens, said in a press release.

“Our initial focus on blood-based diagnostic solutions for MS patients is another example of Siemens Healthineers commitment to shape the future of precision medicine,” Nath added.

NfL is of growing interest as a biomarker for neurodegenerative diseases like MS because its presence in the blood or cerebral spinal fluid (the fluid that surrounds the brain and spinal cord) is a sign of neuron degeneration: NfL protein is released when neurons become damaged.

Previous studies have suggested that measuring NfL levels could be an important tool for monitoring MS progression and response to treatment. The use of blood NfL levels as a reliable predictor of disease worsening and progression in relapsing-remitting MS patients also has been reported.

Clinical trials sponsored by Novartis in MS patients also supported the use of NfL blood levels as a biomarker of a patient’s likely risk of new brain lesions and further brain shrinkage.

Thus, testing NfL blood levels is seen as a potentially powerful tool in helping predict patients’ prognoses and following treatment successes.

The new collaboration will combine Novartis’ knowledge in biomedical research and clinical development with Siemens Healthineers’ expertise in the development of clinical diagnostic tests. Such tests can be used in Siemen Healthineer’s platforms ADVIA Centaur and Atellica, immunoassay systems for blood testing, which are specifically designed for use in hospitals and reference/specialty laboratories.

Blood NfL tests will increase Siemens Healthineers’ portfolio of neurologic assessments, which includes testing of two biomarkers for the diagnosis of Alzheimer’s disease, specifically the amyloid-beta protein Aβ42 and the protein Tau. These tests were recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration.