Quanterix Serum Nf-L Assay Powers Key Trial and Study Results Presented at ECTRIMS 2019
Major Serum Nf-L highlights from ECTRIMS included:
- Powering Drug Trials: Novartis announced that its Phase III ASCLEPIOS trials demonstrate the efficacy of ofatumumab in patients with relapsing MS. Nf-L using Simoa was used as a secondary endpoint and showed reductions after just three months of treatment.
- Therapeutic Effectiveness: Several industry presentations on efficacy and comparative effectiveness of existing disease-modifying therapies in MS included data on Nf-L. Roche announced results of retrospective analyses of its Phase III OPERA I, OPERA II and ORATORIO trials for patients with relapsing-remitting or primary progressive MS treated with Ocrevus, who saw serum Nf-L levels (measured with Simoa) lowered to those of healthy donors. These reductions in Nf-L were accompanied by significant reductions in wheelchair use and disease activity progression.
- Revealing Biology of Disease: Several studies, including recently published data in the Journal of American Medicine (JAMA) Neurology provided greater insights into the biology of MS, connection between inflammation and neurodegeneration, understanding the genetics of MS severity, and how additional Simoa assays such as GFAP can be combined with Nf-L for even greater insights. One study showed serum Nf-L levels rising six years before the onset of MS, suggesting a possible role for the test as an early marker of neuronal damage.
- Moving from Research to the Clinic: Numerous studies were presented further strengthening the role of serum Nf-L as a prognostic and treatment monitoring tool in MS, and supporting future implementation for clinical use. Biogen released data generated in collaboration with Siemens Healthineers using Quanterix/UmanDiagnostics Nf-L antibodies to adapt the Simoa assay onto a routine analyzer platform, bringing promise to a future IVD assay.
“The research presented at ECTRIMS is critical to the MS community. The use cases of Nf-L as a valuable biomarker are growing rapidly,” said Kevin Hrusovsky, CEO, President and Chairman of Quanterix. “Our partnerships with the top academic institutions, research organizations and pharmaceutical companies, in conjunction with our acquisition of UmanDiagnostics, are providing an important opportunity for scientific breakthroughs, which may someday change the lives of patients around the globe.”
According to the National Multiple Sclerosis Society, more than 2.3 million people are impacted by MS worldwide yet diagnosis is often inaccurate or delayed due to the lack of a single test to detect the condition.
Data released from ECTRIMS indicated there were more than 9,000 participants in the conference from more than 100 countries, 1,316 posters, and 1,893 abstracts. Over the past several years, the medical and research community has witnessed mounting support for Nf-L as a reliable biomarker for MS prognosis and treatment monitoring, evidenced by the volume of scientific research validating its application for identifying neurogenerative conditions.
To learn more about Quanterix’ Nf-L assay, click here.
Quanterix is a company that’s digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts.
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Marissa Sweazy, 781-913-8036
Source: Quanterix Corporation