Roche has received CE mark approval of its Elecsys neurofilament light chain (NfL) test, which is designed to detect neuroinflammation in patients with relapsing remitting multiple sclerosis (RRMS).
The test aims to enhance disease monitoring by offering a minimally invasive option for clinicians.
Multiple sclerosis affects over 2.9 million individuals worldwide. Early and consistent monitoring is crucial for effective management, though many face challenges accessing assessments such as MRI scans.
The Elecsys test seeks to address this issue by utilising a simple blood sample to measure NfL, a protein linked to nerve cell damage. This could potentially facilitate more frequent monitoring for patients, aiding in better disease management.
It operates on the company's cobas instruments, providing standardised results regardless of location. This development means that patients may not need to travel to specialist centres for testing, reducing geographic and logistical barriers traditionally associated with multiple sclerosis monitoring.
Roche Diagnostics CEO Matt Sause said: “This approval marks a transformative step forward in how we support adults with RRMS.
“The availability of a simple blood-based test has the potential to complement resource-intensive MRI scans and improve access for patients with RRMS. The Elecsys NfL test will help healthcare providers support timely clinical reassessment, enabling better disease management and more personalised care for patients.”
Primarily found in neurons, NfL serves as a sensitive marker for neuroaxonal damage. The Elecsys test is a quantitative in vitro immunoassay for measuring NfL protein in human serum and plasma, specifically aimed at adult subjects with RRMS.
The US Food and Drug Administration granted the test a breakthrough device designation in November 2023.
Last month, Roche launched the cobas MPX-E donor screening assay, a qualitative in-vitro diagnostic test for detecting and differentiating human immunodeficiency virus (HIV 1 and 2), as well as hepatitis B, C, and E.
