Roche MS Test Gets FDA's 'Breakthrough Device' Designation

The Roche Elecsys NfL test is intended to aid detection of disease activity.

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BASEL, Switzerland — Roche announced that its Elecsys Neurofilament Light Chain test for multiple sclerosis received "Breakthrough Device Designation" from the U.S. Food and Drug Administration.

The Elecsys NfL test is intended to be used as an aid in detection of disease activity in adults aged 18-55 with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), providing critical insights for disease management. 

"Around 2.8 million people are estimated to live with multiple sclerosis. 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 optimization,” said Matt Sause, CEO of Roche Diagnostics. “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."

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 standardized Roche cobas instruments with the confidence of in-vitro diagnostics 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. Elecsys NfL receiving this designation is an important step as the organization strengthens its diagnostics neurology portfolio to meet growing societal needs.

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