Pharma Focus Europe

Roche's Elecsys NfL Test Receives FDA Breakthrough Device Designation for Multiple Sclerosis Support

Friday, November 10, 2023

Roche, a pharmaceutical company, has recently announced that its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This test is designed to assist in the detection of disease activity in adults aged 18-55 with Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS), offering crucial insights for disease management.

Multiple Sclerosis affects an estimated 2.8 million people, and after diagnosis, patients often struggle with managing the disease due to limited access to testing. This can lead to missed opportunities to identify disease progression for optimal treatment. Roche Diagnostics' CEO, Matt Sause, expressed enthusiasm about the potential of the Elecsys NfL test to enhance outcomes for MS patients by providing a minimally invasive blood test with rapid results.

The majority of MS cases (about 85%) are RRMS patients, and many eventually transition to SPMS, where neurologic function deteriorates over time, and disability increases. Detecting disease activity is crucial for RRMS and SPMS patients to make informed decisions regarding disease management.

While the primary focus of the Elecsys NfL test is on Multiple Sclerosis, elevated NfL concentrations have been observed in individuals with other neurodegenerative diseases such as Alzheimer's and Huntington's diseases, as well as in conditions beyond neurology.

The Elecsys NfL test has the potential to enable laboratories to expand MS testing using readily available, automated, and standardized Roche cobas instruments, ensuring in vitro diagnostic (IVD) quality and timely results.

In July 2022, the FDA also granted Breakthrough Device Designation to Roche's Elecsys Amyloid Plasma Panel, a novel solution for early detection of Alzheimer's disease. The designation for Elecsys NfL is a significant step in strengthening Roche's diagnostics neurology portfolio to meet the growing societal needs.

Neurofilament Light Chain (NfL) is a protein found exclusively in neurons and serves as a sensitive indicator of neuroaxonal damage. Under normal conditions, NfL is released at low levels from axons, but this rate increases with age and following neuroaxonal damage. Elevated NfL levels can be detected in cerebrospinal fluid and blood in various acute and chronic neurological disorders. While the primary focus of NfL is Multiple Sclerosis, increased NfL concentrations have been reported in traumatic brain injury, amyotrophic lateral sclerosis, frontotemporal dementia, Alzheimer's disease, Huntington's disease, and other neurodegenerative diseases, as well as in non-neurological conditions.

Once approved, this testing will be accessible globally through the 75,000 Roche instruments available worldwide.

The Breakthrough Devices Program is a voluntary initiative for certain medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is designed to expedite the development and review of these medical devices.

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