News Quanterix Poised to Launch Test That Monitors NfL Levels Quanterix Poised to Launch Test That Monitors NfL Levels Simoa NfL LDT blood test is for neurodegenerative diseases, including MS by Andrea Lobo, PhD | January 12, 2023 Share this article: Share article via email Copy article link Quanterix Corporation‘s laboratory test designed to measure blood levels of neurofilament light chain (NfL) has been validated by the Clinical Laboratory Improvement Amendments (CLIA), an arm of the U.S. Food and Drug Administration (FDA) that regulates laboratory testing. The company now is planning to launch its laboratory developed test, called Simoa NfL LDT, to help monitor neuronal damage in people with neurodegenerative diseases, including multiple sclerosis (MS). The test will be available through Quanterixās Accelerator Laboratory, which is dedicated to biomarker research and clinical sample testing. This laboratory is CLIA-licensed, which ensures quality laboratory testing, and ISO 15189 accredited, meaning it is a competent, impartial, and accurate functioning medical laboratory. Recommended Reading January 2, 2023 Columns by Ed Tobias Could Your Hip Pain Be Related to Your MS Steroid Treatments? āToday is another translational step on our mission. We expect the launch of our CLIA validated NfL blood test to power future therapeutic trials and advance clinical care,ā Masoud Toloue, CEO at Quanterix, said in a company press release. NfL is a protein found on nerve fibers that is released into the spinal fluid and bloodstream when nerve cell damage occurs. In MS, levels of this protein are elevated in the blood, and may help predict disease progression and response to treatment in patients. While this means that NfL levels in circulation could serve as a biomarker of disease progression in people with neurodegenerative conditions, the amount of NfL that actually reaches the blood is difficult to measure using conventional technologies. The Simoa NfL test, initially developed for research purposes, was the first to accurately measure NfL levels in the blood. The test was designed detect single molecules of NfL via an ultra-sensitive immunoassay, which enabled researchers to detect NfL levels with up to 1,000 times greater sensitivity than conventional measurements. Using this test, it was possible to establish a correlation between increased serum NfL levels and neuronal injury in several disorders, including MS, amyotrophic lateral sclerosis, Huntingtonās disease, and Alzheimerās disease. The test has been used in several clinical trials to monitor neurofilament light chain levels, and supported the approvals of a number of therapies, including the CD20 antibody Kesimpta (ofatumumab). āAssessment and monitoring of brain health is incredibly difficult and typically performed in limited fashion by surgery or imaging. We see NfL as not only an important marker for neurodegenerative disease but also a critical measure of brain-related side effects during chemotherapy, CAR T-cell therapy, and stroke,ā Toloue said. Last year, the Simoa NfL test received breakthrough device designation from the FDA as a prognostic parameter to assess the risk of disease activity in people with relapsing-remitting MS. This designation is granted to products that may improve the diagnosis or treatment of life-threatening diseases and is designed to accelerate the platformās development toward regulatory approval. Print This Page About the Author Andrea Lobo, PhD Andrea Lobo holds a PhD in cell biology/neurosciences from the University of Coimbra-Portugal, where she studied stroke biology. As a research scientist for 19 years, she participated in academic projects in multiple research fields, from stroke, gene regulation, addition, and rare diseases. She has authored several research papers in peer-reviewed journals. Tags neurofilament light chain, Quanterix
April 19, 2024 News by Lindsey Shapiro, PhD AAN 2024: Long-term data support early Kesimpta start in relapsing MS
April 18, 2024 Columns by Benjamin Hofmeister Learning how to write a ‘SOAP’ note feels different after an MS diagnosis
April 18, 2024 News by Marisa Wexler, MS AAN 2024: Sustained myelin, nerve cell gains with long-term CNM-Au8