Beckman Coulter Introduces Cutting-Edge Research Use Only Assays for Neurodegenerative Disease Research

New, Fully Automated, High-Throughput RUO Assays offered on Beckman Coulter Immunoassay Analyzers

BREA, Calif., Jan. 15, 2025 /PRNewswire/ -- Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which are emerging as the most important biomarkers in neurodegenerative diseases research, including interventional clinical trials.

"Advancements in Research Use Only (RUO) assays for neurodegenerative diseases mark a transformative step in the field, offering precise tools to unravel disease mechanisms. These assays enable researchers to detect and quantify biomarkers with exceptional sensitivity and specificity, facilitating a deeper understanding of conditions such as Alzheimer's disease," said Dr. Nick Ashton, Senior Director, Biomarker Program at Banner Sun Health Research Institute. "Beckman Coulter Diagnostics' commitment to delivering high-quality RUO assays exemplifies the industry's dedication to empowering scientists. By providing reliable and innovative solutions, they are driving progress toward breakthroughs in early diagnosis, personalized treatment strategies, and ultimately improved patient care. Such developments underscore the critical role of cutting-edge technologies in accelerating the path to effective therapies for these challenging diseases."

"We are thrilled to introduce our initial set of RUO assays enabling neurodegenerative disease research," said Kathleen Orland, Senior Vice President, General Manager, Clinical Chemistry and Immunoassay for Beckman Coulter Diagnostics. "Availability of these assays on our automated, high throughput platforms will fundamentally change workflow, precision, and reliability of biomarker testing for neurodegenerative diseases. Our global install base opens new possibilities for multi-center collaborations to investigate the underlying mechanisms of these devastating conditions."

To effectively replace current testing modalities, blood-based biomarkers need to demonstrate concordance with amyloid PET and CSF tests.

p-Tau217 (phosphorylated Tau217) is a critical biomarker to detect tau and amyloid pathology. Tau and amyloid pathology refer to the abnormal accumulation of tau and amyloid beta proteins in the brain. Current evidence shows that plasma p-Tau217 is a sensitive biomarker present through all stages of AD and in research has shown to distinguish AD from other neurodegenerative disorders. Leveraging the ALZpath p-Tau217 antibody, the new Beckman Coulter Diagnostics assay enables researchers to detect p-Tau217 levels in plasma, providing insights into the formation of tau tangles.

GFAP (Glial Fibrillary Acidic Protein) is a cytoskeletal, intermediate filament protein. While not AD specific, current evidence suggests that detection of increasing GFAP levels in plasma can be used to assess early stages of AD. Furthermore, GFAP may help distinguish AD dementia from other neurodegenerative diseases.ⁱ GFAP levels can also act as a marker for gliosis, a non-specific response to central nervous system damage, in response to neuronal damage from toxins or injury.

NfL (Neurofilament Light Chain) is a key indicator of axonal damage and neurodegeneration, regardless of cause. Elevated levels of NfL in cerebrospinal fluid and blood are associated with several neurodegenerative conditions,ⁱⁱ including AD and Parkinson's disease, and may be used for predicting cognitive decline and monitoring treatment efficacy.

APOE ε4 (Apolipoprotein ε4) gene is the most significant genetic risk factor for developing AD. Beckman Coulter Diagnostics' new APOE ε4 immunoassay offers >99% concordance with PCR genotypingⁱⁱⁱ in only 20 minutes, allowing researchers to explore the genetic underpinnings of neurodegenerative disease risks and patient outcomes without having to resort to costly and time-consuming molecular diagnostics.

These neurogenerative RUO assays are all immediately available for use on the DxI 9000 Immunoassay Analyzer, featuring the proprietary Lumi-Phos PRO substrate that enables development of high-sensitive assays, to support evolving healthcare needs. Additionally, GFAP, NfL, and ApoE4 ε4 assays are also available for use on the Access 2 Immunoassay Analyzer. 

For more information about these new RUO assays and how they can support your research, please visit www.beckmancoulter.com/neuro or contact our customer support team. RUO is for Research Use Only; not for use in diagnostic or therapeutic procedures.

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About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimized lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif., it has more than 11,000 global team members.

© 2025 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. The Danaher trademark is a proprietary mark of Danaher Corporation. 2024-13838

ⁱ Shen XN et al. Plasma Glial Fibrillary Acidic Protein in the Alzheimer Disease Continuum: Relationship to Other Biomarkers, Differential Diagnosis, and Prediction of Clinical Progression. Clin Chem. 2023 Apr 3;69(4):411-421. doi: 10.1093/clinchem/hvad018. PMID: 36861369
ⁱⁱ Plasma NfL Goes the Distance in Alzheimer's. (2019, May 2). ALZFORUM. Retrieved January 2, 2025 from https://www.alzforum.org/news/research-news/plasma-nfl-goes-distance-alzheimers
ⁱⁱⁱ Engel B, Szabo M, Hoffman K, et al. LP067 HIGH-THROUGHPUT, FULLY AUTOMATED IMMUNOASSAY FOR DETECTING ZYGOSITY OF APOLIPOPROTEIN ε4 (APOE ε4) IN PLASMA EDTA. Poster presented at the: Clinical Trials in Alzheimer's Disease (CTAD); October 31, 2024; Madrid, Spain.

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