核心概念
Early detection of MS activity is crucial for disease management and patient outcomes.
要約
The FDA has granted breakthrough device designation to Roche's Elecsys Neurofilament Light Chain (NfL) test for multiple sclerosis (MS). The test aids in detecting disease activity in adults with relapsing-remitting or secondary progressive MS. Rising NfL levels indicate neuroaxonal injury and correlate with MS disease activity. The test offers insights for disease management and treatment monitoring. Elevated NfL levels at baseline are associated with increased future disability risk. The Elecsys NfL test provides a minimally invasive blood draw with rapid results, potentially improving outcomes for MS patients.
統計
"The test is intended to be used as an aid in detection of disease activity in adults aged 18-55 years with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS)."
"Rising NfL levels are a known indicator of neuroaxonal injury and correlate with MS disease activity."
"An analysis of NfL in two large MS cohorts found that elevated levels of the neuronal protein at baseline were associated with large increases in future disability risk."
引用
"For patients with RRMS and SPMS, detection of disease activity is critically important in enabling them and their physicians to make the best possible decisions for the management of the disease." - Roche
"The Elecsys NfL test could help laboratories to scale MS testing on widely available, fully automated, and standardized Roche cobas instruments with the confidence of in-vitro diagnostics quality in a timely manner." - Roche