FDA Breakthrough Designation shines on Roche's Elecsys NfL test, a game-changer for Multiple Sclerosis support

Thursday, November 09, 2023

Roche has recently revealed a significant development with its Elecsys Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS), receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This test is designed to assist in detecting disease activity in adults aged 18-55 with Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS). It aims to provide crucial insights for disease management, addressing challenges in testing accessibility that many MS patients encounter.

Given the estimation of around 2.8 million people living with Multiple Sclerosis, this breakthrough designation is particularly promising. The Elecsys NfL test could prove instrumental in filling the gaps in testing access, potentially preventing missed opportunities for identifying disease progression and optimizing treatment.

Approximately 85% of MS cases are RRMS patients, and a majority eventually transition to SPMS, where neurologic function deteriorates over time, leading to increased disability. The Neurofilament Light Chain (NfL) is a protein exclusive to neurons, serving as a sensitive indicator of neuroaxonal damage. Abnormal elevations in NfL levels can be detected in cerebrospinal fluid and blood in various neurological disorders, making this test versatile beyond its current focus on MS.

The Breakthrough Devices Program by the FDA, designed for medical devices addressing life-threatening or irreversibly debilitating conditions, has expedited the development and review of Roche's Elecsys NfL test. The potential for laboratories to scale MS testing using widely available, automated, and standardized Roche cobas instruments is a significant advantage, ensuring quality and timely results.

While the primary focus of NfL's use is currently in Multiple Sclerosis, there are reported increases in NfL concentrations in individuals with other neurodegenerative diseases, such as Alzheimer's and Huntington's. This suggests a broader application for Elecsys NfL beyond the field of neurology, marking a promising stride in medical advancements.


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