Roche has received CE mark approval for an MS blood test to help monitor nerve damage linked to inflammation in adults with relapsing remitting MS.
The Elecsys Neurofilament Light Chain, or NfL, test measures a protein released when nerve cells are injured.
It is designed to reflect neuroinflammation, or inflammation in the nervous system, in adults diagnosed with relapsing remitting multiple sclerosis.
Roche said the test could complement routine clinical assessments and MRI by measuring biological markers of neuroaxonal damage, which is damage to nerve fibres, linked to neuroinflammation. Requiring only a simple blood sample, collections can be carried out locally, reducing the need for some patients to travel to specialist centres.
Matt Sause, chief executive of Roche Diagnostics, said: “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.”
The test is performed on Roche’s cobas instruments, and the company said it provides standardised and consistent results regardless of where it is carried out.
NfL is a cytoskeletal protein found almost exclusively in neurons and is considered a sensitive indicator of neuroaxonal damage.
Under normal conditions it is released at low levels, but release increases with age and following neuroaxonal damage. Abnormally raised levels can be measured in both cerebrospinal fluid and blood across a range of neurological disorders.
The test was granted Breakthrough Device Designation by the US FDA in November 2023.
Following CE mark approval, broad access to testing will be available through the large number of instruments in countries that accept the CE mark.
