Roche receives CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis
Roche announced that its Elecsys Neurofilament Light Chain (NfL) test has received CE mark approval for the detection of neuroinflammation in patients diagnosed with relapsing remitting multiple sclerosis (RRMS). The test brings meaningful innovation to MS disease management, offering clinicians a minimally invasive way to monitor the biological damage caused by multiple sclerosis. Using a simple blood test to measure NfL – a protein released during nerve cell injury – Elecsys NfL provides a picture of the neuroinflammation associated with multiple sclerosis, and could help to make more regular monitoring a reality for more people living with the disease.
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. Early and regular monitoring of disease activity is critical to optimising treatment, yet some patients can find it difficult to access routine assessments such as MRI scanning that would allow timely detection of changes in their condition. The Elecsys NfL test provides a different type of insight by measuring biological markers of neuroaxonal damage that reflect neuroinflammation. These insights complement routine clinical assessments and MRI, potentially aiding in earlier and better-informed clinical management.
“This approval marks a transformative step forward in how we support adults with relapsing-remitting multiple sclerosis (RRMS),” said Matt Sause, CEO of Roche Diagnostics. “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.”
Performed on Roche’s widely available Cobas instruments, the Elecsys NfL test provides standardised and consistent results, ensuring reliable insights regardless of where the test is carried out. Requiring only a simple blood sample, collections can be done locally, reducing the need for patients to travel to specialist centres. With traditional testing for multiple sclerosis often limited by geographic, financial, or logistical barriers, Elecsys NfL makes frequent monitoring more practical and accessible.
Roche’s Elecsys NfL 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). The test was granted Breakthrough Device Designation by the US FDA in November 2023. Following CE Mark approval, broad access to testing will exist through the large number of instruments currently available in countries accepting CE mark.
