CE Mark Granted for Blood-Based NfL Test to Monitor Neuroinflammation in MS
KEY TAKEAWAYS
- Roche’s Elecsys NfL blood test received CE mark approval for detecting neuroinflammation in relapsing-remitting MS.
- The test measures NfL, a biomarker of neuroaxonal damage, using a minimally invasive blood sample.
- The assay may complement MRI by enabling more accessible and frequent monitoring of disease activity.
Roche has received CE mark approval for its Elecsys Neurofilament Light Chain (NfL) test (Roche, Indianapolis, IN), a blood-based assay designed to detect neuroinflammation in adults with relapsing-remitting multiple sclerosis (RRMS).
The Elecsys NfL test is an in vitro immunoassay that quantifies NfL, a neuronal cytoskeletal protein released into circulation following neuroaxonal injury. Elevated NfL levels are associated with active neuroinflammation and disease activity across multiple neurologic conditions, including MS.
In a statement from Roche, the company announced that the newly approved assay will offer a minimally invasive alternative to traditional monitoring approaches, such as MRI, which can be resource-intensive and less accessible for some patients. By enabling measurement of neuroaxonal damage through a simple blood draw, the test may support more frequent assessment of disease activity and complement routine imaging and clinical evaluation. The test is performed on the Cobas (Roche, Indianapolis, IN) platform, which according to Roche, allows for standardized and consistent results across testing sites. Blood samples can be collected locally, potentially reducing the need for travel to specialized centers and improving access to disease monitoring.
The CE mark enables availability of the Elecsys NfL test in regions recognizing CE certification. The Elecsys NfL test has been granted Breakthrough Device designation by the Food and Drug Administration.
Source
Roche. Roche receives CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis. Published April 12, 2026. Accessed April 13, 2026. https://www.roche.com/media/releases/med-cor-2026-04-13