Siemens Healthineers has inked what it describes as a “master collaboration agreement” with Novartis to help provide diagnostic tests linked to therapies across the drugmaker’s pipeline.
To start, the companies will design and develop a biomarker test aimed at neuroscience programs, and multiple sclerosis specifically—a treatment area that they expect to expand into a $23.5 billion global market by 2025.
The initial immunoassay will measure neurofilament light chain protein levels, found in the blood and cerebrospinal fluid, which are linked to nerve cell injury and a variety of neurological conditions including MS.
Levels of neurofilament light chain in the blood have also been associated with various clinical measures of MS activity and MRI scans showing nerve damage. As a chronic inflammatory disease of the central nervous system, MS sees destruction of neurons’ protective myelin sheath across the brain, optic nerves and spinal cord.
In August, the FDA approved Novartis’ MS treatment Kesimpta for both the relapsing-remitting and secondary progressive forms of the disease. The drug, already approved in leukemia as Arzerra, targets particular immune system B cells expressing CD20.
Earlier this year, Novartis presented data for Mayzent, an S1P receptor modulator for secondary progressive MS, showing that early treatment could slow the course of the disease. However, in many cases, patients and doctors may not be aware that the disease has moved into the secondary progressive stage, and it is often diagnosed late as symptoms become more apparent.
“We are looking forward to our collaboration with Novartis as it promises to yield innovative diagnostic solutions to address critical unmet clinical needs,” said Deepak Nath, president of laboratory diagnostics for Siemens Healthineers.
Elsewhere, Siemens has been developing Aβ42 and Tau protein assays for the diagnosis of Alzheimer’s disease—two diagnostics recently granted breakthrough device designations by the FDA.