Roche ’s Elecsys NfL test, an important aid for those living with Multiple Sclerosis, is granted FDA Breakthrough Device Designation

Roche Elecsys NfL aids in detection of disease activity in adults with Multiple Sclerosis supporting better disease management decisionsElecsys NfL offers a minimally invasive testing option that can provide rapid answers to patients and caregiversNfL has the potential to provide patient insights for other neurological conditions such as Alzheimer ’s and Huntington’s diseasesBasel, 9 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys ® Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The Elecsys NfL test is intended to be used as an aid in detection of disease activity in adults (18-55 years old) with Relapsing-Remitting M ultiple 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 Sclerosis1. 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 optimisation, ” 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.2 The majority of people diagnosed wit...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news