Roche's Elecsys NfL Test Earns FDA Breakthrough Status for MS

Roche's Elecsys Neurofilament Light Chain (NfL) test for multiple sclerosis (MS) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), the company announced. The Elecsys NfL test is designed to help identify disease activity in adults aged 18-55 with relapsing-remitting or secondary progressive multiple sclerosis. It provides important information for managing the disease.Approximately 2.8 million individuals are believed to be living with multiple sclerosis. After being diagnosed, many people struggle to manage their illness because there are significant barriers to accessing testing. "We are thrilled about the potential of Elecsys NfL to enhance outcomes for MS patients through the use of a minimally invasive blood draw that provides fast results."The majority of MS cases, around 85%, are patients with RRMS. Most individuals diagnosed with RRMS eventually progress to SPMS, experiencing a worsening of neurologic function and increased disability over time.While NFL’s primary focus is on its use for multiple sclerosis, elevated levels of NFL have also been observed in those with neurodegenerative diseases like Alzheimer's and Huntington's, as well as in other medical conditions outside of neurology.Roche's Elecsys Amyloid Plasma Panel has been granted Breakthrough Device Designation by the FDA in July 2022, offering a new and innovative solution for early detection of Alzheimer's disease. The designation of Elecsys NfL marks a significant milestone as the organization expands its neurology diagnostics portfolio to address increasing societal demands.