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

Rhea-AI Summary

Beckman Coulter Diagnostics has launched new Research Use Only (RUO) blood-based biomarker immunoassays for neurodegenerative disease research. The assays are designed to assess four key biomarkers: p-Tau217, GFAP, NfL, and APOE ε4, which are important in neurodegenerative diseases research and clinical trials.

The assays are available on the DxI 9000 Immunoassay Analyzer, featuring Lumi-Phos PRO substrate for high-sensitivity testing. GFAP, NfL, and APOE ε4 assays are also available on the Access 2 Immunoassay Analyzer. The APOE ε4 immunoassay offers over 99% concordance with PCR genotyping in just 20 minutes.

These automated, high-throughput platforms aim to improve workflow, precision, and reliability of biomarker testing for neurodegenerative diseases, potentially enabling broader multi-center research collaborations.

Positive

• Launch of new automated high-throughput RUO assays for neurodegenerative disease research
• APOE ε4 immunoassay achieves >99% concordance with PCR genotyping in 20 minutes
• Expansion of testing capabilities on multiple analyzer platforms

Negative

• None.

Insights

Medical Research Analyst

The launch of Beckman Coulter's Research Use Only (RUO) assays represents a significant advancement in neurodegenerative disease research capabilities. The key biomarkers - p-Tau217, GFAP, NfL and APOE ε4 - enable comprehensive analysis of different aspects of neurodegeneration. In simple terms, these are like sophisticated blood tests that can detect early warning signs of brain diseases.

The automated, high-throughput nature of these assays on Beckman's platforms dramatically improves research efficiency. Think of it as upgrading from manual photography development to digital cameras - faster, more precise and more reliable. The concordance with existing testing methods (amyloid PET and CSF) validates their potential clinical utility.

Most notably, the APOE ε4 test achieving >99% concordance with PCR genotyping in just 20 minutes represents a major efficiency breakthrough. This is like getting DNA test results in minutes instead of days, at a fraction of the cost.

Market Research Analyst

For Danaher (DHR), parent company of Beckman Coulter, this product launch strengthens their position in the rapidly growing neurodegenerative disease research market. The global Alzheimer's biomarkers market is projected to reach $2.5 billion by 2028, with blood-based biomarkers representing the fastest-growing segment.

The availability of these assays on Beckman's existing global install base creates a significant competitive advantage. This means immediate market access without requiring customers to purchase new equipment. The automation and high-throughput capabilities address key pain points in neurodegenerative research, potentially driving increased instrument utilization and recurring reagent revenue.

The timing aligns perfectly with growing demand for blood-based biomarkers in Alzheimer's drug development, especially following recent FDA approvals of new treatments. This positions DHR to capture value from both research and potential future diagnostic applications.

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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SOURCE Beckman Coulter Diagnostics

FAQ

What new biomarker assays did Beckman Coulter introduce for neurodegenerative research?

Beckman Coulter introduced RUO assays for four key biomarkers: p-Tau217, GFAP, NfL, and APOE ε4, designed for neurodegenerative disease research.

What is the accuracy of Beckman Coulter's new APOE ε4 immunoassay?

The new APOE ε4 immunoassay offers greater than 99% concordance with PCR genotyping and delivers results in 20 minutes.

Which analyzers are compatible with Beckman Coulter's new neurodegenerative assays?

All assays are available on the DxI 9000 Immunoassay Analyzer, while GFAP, NfL, and APOE ε4 assays are also available on the Access 2 Immunoassay Analyzer.

What is the significance of p-Tau217 in Beckman Coulter's new assay lineup?

p-Tau217 is a critical biomarker that detects tau and amyloid pathology, present through all stages of Alzheimer's Disease, and helps distinguish AD from other neurodegenerative disorders.