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Roche's novel Elecsys NfL test secures FDA Breakthrough Device Designation for multiple sclerosis

Roche has recently announced that its Elecsys® Neurofilament Light Chain (NfL) test, developed for multiple sclerosis (MS), has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

This test is designed for adults aged 18-55 with either relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), providing valuable insights for effective disease management. Given that around 85% of MS cases fall under RRMS, and many eventually transition to SPMS, the ability to detect disease activity is crucial for informed decision-making by patients and physicians.

While the primary focus of the Elecsys NfL test is on multiple sclerosis, its applications extend to other neurodegenerative conditions such as Alzheimer's and Huntington's diseases. Conducted on Roche cobas instruments, the test offers scalability and standardized, automated results of in-vitro diagnostics quality. This Breakthrough Device Designation signifies a significant stride for Roche, strengthening its diagnostics neurology portfolio to cater to the evolving needs of society.



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