Roche receives USFDA Breakthrough Device Designation for Multiple Sclerosis test Elecsys NfL

Approximately 85% of MS cases are RRMS patients. The majority of people diagnosed with RRMS eventually transition to SPMS, in which neurologic function worsens over time and disability increases. For patients with RRMS and SPMS, detection of disease activity is critically important in enabling them and their physicians to make the best possible decisions for the management of the disease.

Although the current spotlight for NfL’s intended use is Multiple Sclerosis, increases in NfL concentrations have been reported in individuals with other neurodegenerative diseases, such as Alzheimer’s and Huntington’s diseases and in indications beyond neurology.

Elecsys NfL has the potential to help laboratories to scale MS testing on widely available, fully automated and standardised Roche cobas instruments with the confidence of IVD quality, in a timely manner.

In July 2022, the FDA also granted Breakthrough Device Designation to Roche’s Elecsys Amyloid Plasma Panel, an innovative new solution to enable Alzheimer’s disease to be detected earlier.

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