Roche's Elecsys NfL Test For Multiple Sclerosis Receives Breakthrough Device Designation From FDA

(RTTNews) - Roche's (RHHBY) Elecsys Neurofilament Light Chain or NfL test for Multiple Sclerosis or MS received Breakthrough Device Designation from the U.S. Food and Drug Administration, the company said in a statement on Thursday.

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.

The company noted that Elecsys NfL offers a minimally invasive testing option that can provide rapid answers to patients and caregivers.

The company said the NfL has the potential to provide patient insights for other neurological conditions such as Alzheimer's and Huntington's diseases.

In July 2022, the FDA also granted Breakthrough Device Designation to Roche's Elecsys Amyloid Plasma Panel, an innovative new solution to enable Alzheimer's disease to be detected earlier.

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