Roche’s Elecsys NfL test is granted FDA Breakthrough Device Designation

Nov. 10, 2023
Roche Elecsys NfL is intended to aid in the detection of disease activity in adults with multiple sclerosis, supporting better disease management decisions.

Roche announced 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 multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), providing critical insights for disease management. 

Although the current spotlight for NfL’s intended use is multiple sclerosis, increases in NfL concentrations have been reported in individuals with other neurodegenerative diseases, such as Alzheimer’s and Huntington’s diseases and in indications beyond neurology.

Elecsys NfL has the potential to 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 release