Siemens Healthineers received European approval for a blood test designed to help predict the risk of recurrence among patients with relapsing multiple sclerosis.
The company’s CE-marked in vitro diagnostic measures the amount of neurofilament light chain proteins found in serum and plasma, which are released into the bloodstream when the brain’s neurons are under siege. When combined with MRI brain scans and other clinical lab tests, it aims to predict which adult patients may have a higher or lower risk of MS disease activity within the following two years.
“Neurofilament light chain, or NfL, has emerged as a leading biomarker of nerve cell damage,” Siemens Healthineers’ head of diagnostics R&D, Dennis Gilbert, said in a statement. “Having access to a test that measures this protein capable of crossing the blood-brain barrier to support earlier prognostication of disease activity would be a critical scientific advancement for MS patients.”
The test—run on the company’s Atellica IM and the ADVIA Centaur analyzers—is the result of a years-long collaboration with Novartis, which launched in 2020 shortly after the drugmaker received an FDA approval for its Kesimpta therapy for relapsing-remitting and secondary progressive MS. Novartis would also go on to collect the first U.S. green light for a biosimilar MS drug, with its version of Biogen’s blockbuster Tysabri.
“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,” Gilbert said. “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.”
Elevated levels of neurofilament light chain, in both the blood and cerebrospinal fluid, are also being studied across a range of neurological conditions where damaged nerve cells serve as a hallmark of the disease—such as dementia and amyotrophic lateral sclerosis, the motor neuron disease commonly known as ALS.
Meanwhile, NfL was incorporated into Labcorp’s blood test aimed at Alzheimer’s disease last fall, alongside measurements of hallmark amyloid and tau proteins.