News Blood Biomarker Test Granted Breakthrough Device Status by FDA Blood Biomarker Test Granted Breakthrough Device Status by FDA by Lindsey Shapiro, PhD | April 28, 2022 Share this article: Share article via email Copy article link Quanterixās ultra-sensitive blood test that measures a biomarker of nerve damage in people with multiple sclerosis (MS) has been granted a breakthrough device designation by U.S. regulators. It is thought that the test, which employs the companyās Simoa technology, can accurately predict the risk of disease activity in people with relapsing-remitting MS (RRMS) by measuring blood levels of neurofilament light chain (NfL). The breakthrough device designation is granted by the U.S. Food and Drug Administration (FDA) to products that offer ways to more effectively diagnose or treat life-threatening diseases. While the designation is designed to accelerate the platformās development toward regulatory approval, it does not guarantee that it will eventually be approved. āObtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022,ā Kevin Hrusovsky, chairman and CEO of Quanterix and founder of Powering Precision Health, said in a press release. āWe are pleased to have the opportunity to work with the FDA to help advance the Quanterix Simoa NfL test towards regulatory approval.ā Recommended Reading April 26, 2022 News by Marisa Wexler, MS Trial of Metformin-Clemastine Combo Enrolls First Patient NfL is a protein found on nerve cell projections, called axons, that is released into the bloodstream when nerve cell damage occurs. Its levels are elevated in the blood of MS patients, and have been shown to be correlated with signs of disease progression in RRMS. The protein has thus emerged as a promising biomarker for identifying patients who are at risk for a more severe disease course. SimoaĀ (standing for SIngle MOlecule Array) technology is a fully-automated platform that detects single molecules of proteins, DNA, or RNA when bound to antibody-coated beads. Several different biomarkers could be detected in a single experiment with the approach. The platform can detect NfL levels in human blood samples with up to 1,000 times greater sensitivity than conventional measurements, according to Quanterix. This means that subtle changes can be captured earlier and less invasively than with other approaches. The company believes the test can identify RRMS patients who are at an increased risk of relapse within the next four years. This may help doctors tailor a more effective treatment strategy for each individual. āFor the more than two million people suffering from MS worldwide, thereās an important need for more informed and effective treatment options,ā Hrusovsky said. Simoaās utility was demonstrated in a large, international study recently published in The Lancet Neurology.Ā In that study, an international team of researchers used the Simoa assay to analyze blood NfL levels in more than 5,000 healthy adults. The team used the data to establish reference ranges of NfL, which were corrected for age and body-mass index, a measure of body fat. They then created an online app that clinicians can use to calculate these reference ranges for each patient. Among 1,313 people with MS, NfL levels were able to predict the risk of both acute (i.e. relapses, brain lesions) and chronic (i.e. disability worsening) disease activity. Researchers noted that NfL levels might also be used as a way of monitoring the effectiveness of some MS treatments. Recommended Reading April 8, 2022 News by Lindsey Shapiro, PhD MS Patients May Meet Criteria for Sjƶgrenās Diagnosis, Study Reports Quanterix also noted the Simoa platform was referenced in at least 20 studies recently presented at the American Academy of Neurology annual meeting, further validating its potential utility. āThere has been an ever-growing body of research with the Simoa NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring,ā said Mark S. Freedman, MD, professor of neurology and director of multiple sclerosis research at the Ottawa Hospital. āThe FDAās grant of Breakthrough Device designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition,ā added Freedman. Last year, Quanterixās phospho-Tau 181 test, which also uses Simoa technology, received breakthrough device status for its use in monitoring disease progression in people with Alzheimerās disease. Print This Page About the Author Lindsey Shapiro, PhD Lindsey earned her PhD in neuroscience from Emory University in Atlanta, where she studied novel therapeutic strategies for treatment-resistant forms of epilepsy. She was awarded a fellowship from the American Epilepsy Society in 2019 for this research. Lindsey also previously worked as a postdoctoral researcher, studying the role of inflammation in epilepsy and Alzheimerās disease. Tags biomarker, neurofilament light chain, NfL levels, Quanterix
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