Siemens Healthineers gets EU CE mark for NfL blood test for MS
Lab-based test would be used to test protein levels in relapsing MS
Siemens Healthineers has received the CE mark in Europe for a lab-based blood test that measures the levels of neurofilament light chain, known as NfL — a protein that gets released into the bloodstream upon damage to nerve cells — in adults with relapsing forms of multiple sclerosis (MS).
Used alongside clinical and imaging data, the test may help predict which patients, ages 18 to 55, are most likely to have signs of new or worsening disease activity on MRI scans over the next two years. The NfL blood test could offer opportunities to intervene early and better manage the disease, according to the company.
“While there is no cure for MS, treatments exist to decrease the frequency of relapses, thought to be associated with nerve cell damage and disease progression. What patients still need is an easily accessible, cost-effective, and accurate blood-based test that would indicate early signs of neuronal injury and disease activity,” Dennis Gilbert, PhD, Siemens Healthineers’ head of research, development, and innovation for diagnostics, said in a company press release.
“Neurofilament light chain, or NfL, has emerged as a leading biomarker of nerve cell damage,” Gilbert said.
CE marking indicates that the test has been checked by a notified body, in this case coded with the four-digit number 0197, and complies with European Union standards for medical devices. Siemens Healthineers expects a market launch in Europe later this year, the company announced in the release, noting, however, that the product is not for sale in the U.S.
NfL blood test developed in partnership with Novartis
In MS, the immune system mistakenly attacks the myelin sheath, a covering that protects nerve fibers, causing regions of damage called lesions. While lesions can be visualized in MRI scans, these scans are normally done several months apart — meaning they may not detect early changes in lesion size and activity to drive prompt treatment modifications.
As nerve cells are progressively damaged in MS, they release a structural protein called NfL into the cerebrospinal fluid, the liquid surrounding the brain and spinal cord. That protein then reaches circulation after crossing the blood-brain barrier, a semipermeable membrane that shields the brain from harmful substances.
This means that measuring NfL in the blood can allow researchers to determine how much damage is occurring in the brain, providing a noninvasive test to routinely monitor nerve cell damage in MS.
Having access to a test that measures this protein capable of crossing the blood-brain barrier to support earlier prognostication [prediction] of disease activity would be a critical scientific advancement for MS patients.
Further, because higher levels of NfL are linked to faster disease progression and predict worse disability, the test may also be used to predict certain disease outcomes in the near term.
“Having access to a test that measures this protein capable of crossing the blood-brain barrier to support earlier prognostication [prediction] of disease activity would be a critical scientific advancement for MS patients,” Gilbert said.
Siemens Healthineers’ test, which results from a long-standing collaboration with Novartis, uses specific antibodies to detect the presence and measure the levels of NfL in blood samples. It is designed to run on the company’s Atellica IM Analyzer and ADVIA Centaur XP/XPT automated immunoassay systems.
CE Marking is used to monitor and regulate goods sold within the European Union. According to the company, the NfL blood test is the first of its kind to be given the CE mark.
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