New blood test may help track MS disease between relapses
Simple tool could support more frequent monitoring of activity
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A CE mark, which means a test meets standards for safety, health, and environmental protection in the European Union.
- Roche’s Elecsys NfL blood test received EU approval to help monitor neuroinflammation in relapsing-remitting multiple sclerosis.
- The test measures NfL, a protein that reflects nerve damage linked to multiple sclerosis.
- It may allow more frequent monitoring and complement MRI to support earlier treatment decisions.
A blood test being developed by Roche to measure a marker of nerve cell damage has received CE mark approval for the detection of neuroinflammation in people with relapsing-remitting multiple sclerosis (RRMS).
Called Elecsys Neurofilament Light Chain (NfL), the test is designed to measure NfL levels, which are increased in many neurological conditions due to nerve cell damage. In RRMS, it could enable more frequent monitoring of disease activity, potentially supporting earlier treatment decisions.
A CE mark means the test meets standards for safety, health, and environmental protection in the European Union (EU). In practice, it allows a product to be marketed across the EU and other countries that align with EU standards and recognize the CE mark.
Blood test offers new way to monitor MS disease activity
“This approval marks a transformative step forward in how we support adults with relapsing-remitting multiple sclerosis,” Matt Sause, CEO of Roche Diagnostics, said in a company press release.
In multiple sclerosis (MS), the immune system launches a misguided attack on the brain and spinal cord, which can damage nerves and lead to symptoms such as numbness, weakness, balance problems, and vision changes.
In RRMS, the most common MS type, these inflammatory attacks tend to come in waves, with patients experiencing periods of sudden symptom worsening, called relapses, followed by periods of recovery.
While many disease-modifying therapies are available for RRMS, which can reduce relapses and brain lesions and slow the accumulation of disability, some patients will continue to experience disease activity despite treatment.
Early and regular monitoring of MS disease activity is essential to guide treatment decisions, but this is mostly done with MRI scans, which are costly and can be difficult to access in some regions.
Simple blood test may support more frequent monitoring
Because Roche’s Elecsys NfL test requires only a simple blood sample, it may be used alongside existing monitoring tools and allow doctors to monitor disease activity more often.
Higher levels of NfL can reflect nerve damage linked to inflammation, which may help doctors track disease activity between clinical visits and MRI scans and support earlier treatment decisions.
“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,” Sause said.
The Elecsys NfL assay is performed on Roche’s widely available cobas instruments, which are designed to deliver consistent results across different testing locations.
The test was granted Breakthrough Device designation in the U.S., a status meant to speed the development and review of medical devices that may offer a more effective way to diagnose or manage serious conditions.
Bernadette
Then is it actually available now in the US? I remember reading about this more than a year ago. I’d like to know if this is currently now being used in clinical practice?