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FDA Granted Breakthrough Designation to Roche's Elecsys NfL Test for Multiple Sclerosis

Roche has recently disclosed that the Elecsys Neurofilament Light Chain (NfL) test designed for Multiple Sclerosis (MS) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation is reserved for medical devices with the potential to enhance treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The Elecsys NfL test is specifically intended to assist in detecting 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.

Approximately 2.8 million people are estimated to live with Multiple Sclerosis, and post-diagnosis, many encounter challenges in managing the disease due to limited access to testing. This can result in missed opportunities to identify disease progression and optimize treatment. While the primary focus of the Elecsys NfL test is on MS, it has broader implications, as elevated NfL concentrations have been observed in individuals with various neurodegenerative diseases like Alzheimer's and Huntington's diseases, extending beyond the scope of neurology.

The Elecsys NfL test has the potential to facilitate MS testing in laboratories using widely available, automated, and standardized Roche cobas instruments. NfL, an abundant protein exclusively present in neurons, serves as a sensitive indicator of neuroaxonal damage. Abnormal levels of NfL can be detected in cerebrospinal fluid and blood across acute and chronic neurological disorders. Moreover, elevated NfL concentrations have been reported in conditions such as traumatic brain injury, amyotrophic lateral sclerosis, frontotemporal dementia, Alzheimer's disease, Huntington's disease, and other neurodegenerative diseases.

The Breakthrough Devices Program, which the Elecsys NfL test has been included in, is a voluntary initiative aimed at expediting the development and review of medical devices catering to life-threatening or irreversibly debilitating diseases. This recent designation underscores the potential significance of the Elecsys NfL test in advancing diagnostic capabilities for MS and related neurological conditions.

https://www.roche.com/media/releases/med-cor-2023-11-09

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