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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via LinkedIn, X, and Facebook.
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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