Quanterix Corporation (NASDAQ: QTRX) is revolutionizing scientific discovery and breakthrough diagnostics through their ultrasensitive biomarker detection. Today, the company has announced the validation of a Laboratory Developed Test (LDT) to quantitatively measure neurofilament light chain (NfL) in serum. This new test can be used to detect possible neurodegenerative conditions and other forms of neuronal or central nervous system damage.
The Neurofilament light chain (NfL) is a vital biomarker for detecting and monitoring neuronal damage across a range of neurological disorders. Its presence in the interstitial fluid and cerebrospinal fluid (CSF) can be detected by conventional immunoassay technologies, however, its detection in serum and plasma is made possible through the use of the Simoa NfL kit. This RUO or research use only kit has enabled us to measure NfL concentrations which are 50- to 100-fold lower than in CSF and can provide insight into the severity of neuronal damage.
Simoa NfL is the gold standard for measuring neuronal damage and has been widely adopted in clinical trials across a variety of neurological disorders, such as ALS, Huntington’s disease, HIV infection, Parkinsonian disorders, TBI, concussion, small vessel disease, Alzheimer’s disease, and MS. Recent studies utilizing Simoa NfL measurements have been used to assess the efficacy of several approved therapeutics, such as Novartis’ Kesimpta (ofatumumab) for MS, and to monitor the progress of trials related to Alzheimer’s disease, like Eisai’s lecanemab Phase 3 Clarity AD study, which was presented at the recent Clinical Trials for Alzheimer’s Disease (CTAD) conference. Furthermore, the Simoa NfL test has provided critical reference range values for the interpretation of measurements from individuals in clinical care settings.
Last year, the US Food and Drug Administration (FDA) granted Breakthrough Device designation to Quanterix’s Neurofilament light (NfL) test, recognizing its capability to assess the risk of disease activity in those diagnosed with relapsing-remitting multiple sclerosis (RRMS). This program expedites the development, assessment, and review processes, providing quicker access to breakthrough technologies and devices, bringing hope to those suffering from life-threatening diseases with an unmet medical need.
Masoud Toloue, CEO of Quanterix, is excited to announce the launch of their CLIA validated NfL blood test. This test is a critical measure for brain health, and can be used to assess the effects of chemotherapy, CAR T-cell therapy, stroke, and neurodegenerative diseases. It is an important step forward in their mission to provide better monitoring and assessment of brain health, and to make it easier for clinicians to diagnose and treat these conditions.
Quanterix’s Accelerator Laboratory offers clinical diagnostic testing and translational research with unparalleled precision and accuracy. Certified by CLIA and ISO 15189, this cutting-edge lab is now showcasing the revolutionary Simoa NFL LDT. Step into the future of diagnosis and research with this groundbreaking technology.
About Quanterix
Quanterix is revolutionizing the way we understand and manage disease through its ultrasensitive biomarker detection technology. Its Simoa® technology delivers unparalleled sensitivity and flexibility, allowing for proteins to be quantified far below the Limit of Quantification of conventional analog methods. For nearly two decades, Quanterix has been a trusted partner of the scientific community, providing precision instruments, digital immunoassay technology and a CLIA-certified Accelerator laboratory to support groundbreaking research in neurology, oncology, immunology, cardiology and infectious disease. These advancements have been published in over 2,000 peer-reviewed journals, enabling a deeper understanding of disease and driving the future of medical care.
Forward-Looking Statements
Quanterix is making forward-looking statements that could have a major impact on its future. These statements include words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” and “intend.” We are aware of the risks and uncertainties that come with these projections, and we take the necessary steps to ensure that they are accurate and up-to-date. We are committed to keeping our stakeholders informed and updated on any changes that may occur.