Breakthrough Device Designation Granted to Roche’s Elecsys Neurofilament Light Chain Test for Multiple Sclerosis

Roche’s Elecsys neurofilament light chain (NfL) test (Basel, Switzerland) received breakthrough device designation from the Food and Drug Administration (FDA). The test is intended to be used to detect disease activity in the serum and plasma of adults aged 18 to 55 years with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS). NfL is a protein found in neurons that is an indicator of neuroaxonal damage.

The FDA’s breakthrough device designation is intended to expedite the development and review of medical devices or drugs used for more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.

According to a statement by 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.”