• Strategy
  • Payers
  • AI
  • Cybersecurity
  • Device Development
  • Studies/Published Research
  • Ethics
  • Regulatory
  • Digital Biomarkers
  • Data Science
  • Companion Diagnostics
  • Clinical Care
  • Digital Therapeutics
  • Academic Research
  • Virtual Reality
  • RWE
  • Digital Endpoints
  • Medical Devices (Class II and Class III)
  • Commercialization
  • Clinical Trials
  • Drug-Device Combinations
  • SaMD
  • Remote Patient Monitoring
  • Patient Engagement
  • Profiles/Q&A

FDA Awards Breakthrough Device Designation to Roche's Neurofilament Light Chain Test for MS


The Elecsys NfL test is designed to aid in detecting disease activity and to offer insights in disease management for patients with multiple sclerosis.

The FDA has awarded Breakthrough Device Designation to Roche’s Elecsys Neurofilament Light Chain (NfL) test for multiple sclerosis (MS). The Elecsys NfL test is designed to aid in detecting disease activity and to offer insights in disease management for individuals 18 to 55 years of age with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS).

“Around 2.8 million people are estimated to live with Multiple Sclerosis1. After diagnosis, many face challenges with managing their disease due to significant gaps in access to testing. This can lead to missed opportunities to detect disease progression in support of treatment optimisation,” said Matt Sause, CEO of Roche Diagnostics, in a press release. “We are excited about the potential Elecsys NfL has to improve outcomes for MS patients by offering a minimally invasive blood draw that can deliver rapid results.”

The FDA’s Breakthrough Devices Program addresses certain medical devices that offer a more effective treatment option or diagnosis for life-threatening or irreversibly impairing conditions. The program helps to expedite the development and review of these breakthrough devices.
NfL is a protein that is exclusively found in neurons and is a sensitive indicator of neuroaxonal damage. NfL is typically released from axons at low levels, but this release rate may hasten with age or after neuroaxonal damage. Abnormal increased levels of the protein may be found in cerebrospinal fluid and blood across various acute and chronic neurological disorders.

RRMS represents approximately 85% of total MS cases. Most patients who develop RRMS will eventually progress to SPMS, which involves worsening neurologic function and increasing disability. Detecting disease activity in patients with RRMS and SPMS is vital to enable these patients and their physicians to make the best disease management decisions for their quality of life.

In addition to the intended use of NfL for different MS types, Roche reported NfL concentration growth in patients with neurodegenerative diseases, such as traumatic brain injury, amyotrophic lateral sclerosis, frontotemporal dementia, Alzheimer disease, Huntington disease, and for indications beyond neurology.

Elecsys NfL may enable laboratories to scale MS testing in a timely manner for widely available, fully automated, and standardized Roche cobas devices with the confidence of IVD quality, the company stated in a press release.

The FDA granted Breakthrough Device Designation in July 2022 to the Elecsys Amyloid Plasma Panel, which Roche said helps detect Alzheimer disease earlier in development.

Roche added that the latest breakthrough designation represents a vital step as the company strengthens its diagnostics neurology portfolio as needs for new tools to fight these diseases grow.

Should the device gain full FDA approval, Roche said broad global access will exist across 75,000 instruments the company currently has available around the globe.


Roche’s Elecsys NfL test, an important aid for those living with Multiple Sclerosis, is granted FDA Breakthrough Device Designation. Roche. News release. November 9, 2023. https://www.roche.com/media/releases/med-cor-2023-11-09

© 2024 MJH Life Sciences

All rights reserved.