Beckman Coulter Introduces Cutting-Edge Research Use Only Assays for Neurodegenerative Disease Research
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.
Beckman Coulter Diagnostics ha lanciato nuovi immunoassay basati su biomarker ematici per uso di ricerca (RUO) dedicati alla ricerca sulle malattie neurodegenerative. Gli assay sono progettati per valutare quattro biomarker chiave: p-Tau217, GFAP, NfL e APOE ε4, fondamentali nella ricerca e negli studi clinici sulle malattie neurodegenerative.
Gli assay sono disponibili sull'Analyzer di immunoassay DxI 9000, dotato del substrato Lumi-Phos PRO per test ad alta sensibilità. Gli assay per GFAP, NfL e APOE ε4 sono anche disponibili sull'Access 2 Immunoassay Analyzer. L'immunoassay per APOE ε4 offre oltre il 99% di concordanza con il genotipizzazione PCR in soli 20 minuti.
Queste piattaforme automatizzate ad alta capacità puntano a migliorare il flusso di lavoro, la precisione e l'affidabilità dei test biomarkeri per le malattie neurodegenerative, potenzialmente permettendo collaborazioni di ricerca multi-centro più ampie.
Beckman Coulter Diagnostics ha lanzado nuevos inmunoensayos basados en biomarcadores en sangre para uso exclusivo en investigación (RUO) enfocados en la investigación de enfermedades neurodegenerativas. Los ensayos están diseñados para evaluar cuatro biomarcadores clave: p-Tau217, GFAP, NfL y APOE ε4, que son importantes en la investigación de enfermedades neurodegenerativas y ensayos clínicos.
Los ensayos están disponibles en el Analizador de inmunoensayo DxI 9000, que cuenta con el sustrato Lumi-Phos PRO para pruebas de alta sensibilidad. Los ensayos para GFAP, NfL y APOE ε4 también están disponibles en el Analizador de Inmunoensayos Access 2. El inmunoensayo de APOE ε4 ofrece más del 99% de concordancia con la genotipificación por PCR en solo 20 minutos.
Estas plataformas automatizadas de alto rendimiento tienen como objetivo mejorar el flujo de trabajo, la precisión y la fiabilidad de las pruebas de biomarcadores para enfermedades neurodegenerativas, potencialmente permitiendo colaboraciones de investigación multicéntricas más amplias.
벡맨 쿨터 진단이 신경퇴행성 질환 연구를 위한 혈액 기반 바이오마커 면역 분석법(Research Use Only, RUO)을 출시했습니다. 이 분석법은 신경퇴행성 질환 연구 및 임상 시험에서 중요한 네 가지 핵심 바이오마커인 p-Tau217, GFAP, NfL 및 APOE ε4를 평가하도록 설계되었습니다.
이 분석법은 고감도 테스트를 위해 Lumi-Phos PRO 기질이 특징인 DxI 9000 면역 분석기에서 사용할 수 있습니다. GFAP, NfL 및 APOE ε4 분석법은 Access 2 면역 분석기에서도 사용 가능합니다. APOE ε4 면역 분석법은 단 20분 만에 PCR 유전자형 지정과 99% 이상의 일치를 제공합니다.
이러한 자동화된 고처리량 플랫폼은 신경퇴행성 질환에 대한 바이오마커 테스트의 작업 흐름, 정밀성 및 신뢰성을 개선하고, 잠재적으로 더 넓은 다중 센터 연구 협력을 가능하게 합니다.
Beckman Coulter Diagnostics a lancé de nouveaux immunoessais basés sur des biomarqueurs sanguins à usage de recherche uniquement (RUO) pour la recherche sur les maladies neurodégénératives. Les tests sont conçus pour évaluer quatre biomarqueurs clés : p-Tau217, GFAP, NfL et APOE ε4, qui sont importants dans la recherche et les essais cliniques sur les maladies neurodégénératives.
Les tests sont disponibles sur le DxI 9000 Immunoassay Analyzer, avec le substrat Lumi-Phos PRO pour des tests de haute sensibilité. Les tests pour GFAP, NfL et APOE ε4 sont également disponibles sur l'Access 2 Immunoassay Analyzer. L'immunoessai APOE ε4 offre plus de 99 % de concordance avec le génotypage PCR en seulement 20 minutes.
Ces plateformes automatisées à haut débit visent à améliorer le flux de travail, la précision et la fiabilité des tests de biomarqueurs pour les maladies neurodégénératives, permettant potentiellement des collaborations de recherche multicentrique plus larges.
Beckman Coulter Diagnostics hat neue Immunoassays auf Blutbasis für Forschungszwecke (RUO) zur Untersuchung neurodegenerativer Erkrankungen eingeführt. Die Assays sind darauf ausgelegt, vier wichtige Biomarker zu bewerten: p-Tau217, GFAP, NfL und APOE ε4, die eine bedeutende Rolle in der Forschung und klinischen Studien zu neurodegenerativen Erkrankungen spielen.
Die Assays sind auf dem DxI 9000 Immunoassay-Analyzer verfügbar, der mit dem Lumi-Phos PRO Substrat für hochsensible Tests ausgestattet ist. GFAP-, NfL- und APOE ε4-Assays sind auch auf dem Access 2 Immunoassay-Analyzer verfügbar. Der APOE ε4 Immunoassay bietet in nur 20 Minuten mehr als 99% Übereinstimmung mit der PCR-Genotypisierung.
Diese automatisierten Hochdurchsatz-Plattformen zielen darauf ab, den Arbeitsablauf, die Präzision und die Zuverlässigkeit von Biomarkertests für neurodegenerative Erkrankungen zu verbessern und potenziell breitere multizentrische Forschungskooperationen zu ermöglichen.
- 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
- None.
Insights
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.
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
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
"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 >
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
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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;
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