Beckman Coulter Diagnostics Launches Industry First Fully Automated, High Throughput BD-Tau Research Use Only Immunoassay Test, Advancing Neurodegenerative Clinical Research
Beckman Coulter Diagnostics, a Danaher (NYSE:DHR) company, has launched the industry's first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test. The test is available on the DxI 9000 Immunoassay Analyzer and Access 2 Analyzer platforms.
BD-Tau represents a significant advancement in neurodegenerative research, offering enhanced specificity compared to traditional tau markers. The test directly detects brain-derived tau in blood, providing a more precise indicator of neurodegeneration. Additionally, the company announced the development of an A尾-42 RUO immunoassay test, marking progress toward their FDA Breakthrough Device Designation for a p-Tau 217/A尾-42 ratio test.
Beckman Coulter Diagnostics, societ脿 del gruppo Danaher (NYSE:DHR), ha lanciato il primo test immunodosaggio completamente automatizzato del settore per la ricerca, il Brain-derived Tau (BD-Tau) RUO. Il test 猫 disponibile sulle piattaforme DxI 9000 Immunoassay Analyzer e Access 2 Analyzer.
BD-Tau rappresenta un importante progresso nella ricerca sulle malattie neurodegenerative, offrendo una specificit脿 migliorata rispetto ai tradizionali marker tau. Il test rileva direttamente la tau di origine cerebrale nel sangue, fornendo un indicatore pi霉 preciso della neurodegenerazione. Inoltre, l'azienda ha annunciato lo sviluppo di un immunodosaggio A尾-42 RUO, passo avanti verso la Designazione di Dispositivo Breakthrough della FDA per un test basato sul rapporto p-Tau217/A尾-42.
Beckman Coulter Diagnostics, una compa帽铆a de Danaher (NYSE:DHR), ha lanzado el primer ensayo inmunol贸gico totalmente automatizado del sector para uso en investigaci贸n: el Brain-derived Tau (BD-Tau) RUO. El ensayo est谩 disponible en las plataformas DxI 9000 Immunoassay Analyzer y Access 2 Analyzer.
BD-Tau supone un avance significativo en la investigaci贸n de enfermedades neurodegenerativas, ofreciendo una especificidad mejorada frente a los marcadores tau tradicionales. El ensayo detecta directamente la tau derivada del cerebro en sangre, proporcionando un indicador m谩s preciso de la neurodegeneraci贸n. Adem谩s, la compa帽铆a anunci贸 el desarrollo de un ensayo inmunol贸gico A尾-42 RUO, avanzando hacia la Designaci贸n de Dispositivo Breakthrough de la FDA para una prueba con la relaci贸n p-Tau217/A尾-42.
Beckman Coulter Diagnostics(雼る倶項堨偓, NYSE:DHR)電� 鞐呹硠 斓滌磮鞚� 鞕勳爠 鞛愲彊頇旊悳 鞐瓣惮鞖�(RUO) Brain-derived Tau(BD-Tau) 氅挫棴旄§爼瓴�靷�毳� 於滌嫓頄堨姷雼堧嫟. 頃措嫻 瓴�靷姅 DxI 9000 Immunoassay Analyzer鞕� Access 2 Analyzer 頂岆灚韽检棎靹� 鞚挫毄頃� 靾� 鞛堨姷雼堧嫟.
BD-Tau電� 鞁犼步韲错枆靹� 歆堩櫂 鞐瓣惮鞐� 鞛堨柎 欷戩殧頃� 歆勳爠鞙茧, 旮办〈鞚� 韮�鞖� 毵堨护氤措嫟 頄レ儊霅� 韸轨澊靹�鞚� 鞝滉车頃╇媹雼�. 鞚� 瓴�靷姅 順堨鞐愳劀 歆侅爲 雵� 鞙犽灅 韮�鞖半ゼ 瓴�於滍暣 鞁犼步韲错枆鞚� 氤措嫟 鞝曧檿頃橁矊 臧�毽偟雼堧嫟. 霕愴暅 須岇偓電� A尾-42 RUO 氅挫棴旄§爼瓴�靷� 臧滊皽霃� 氚滍憸頄堨溂氅�, p-Tau217/A尾-42 牍勳湪 瓴�靷棎 雽�頃� FDA鞚� Breakthrough Device 歆�鞝� 須嶋摑鞚� 頄ロ暅 歆勳爠鞚� 鞚措（瓿� 鞛堨姷雼堧嫟.
Beckman Coulter Diagnostics, une soci茅t茅 du groupe Danaher (NYSE:DHR), a lanc茅 le premier immunodosage enti猫rement automatis茅 du secteur 脿 usage de recherche : le Brain-derived Tau (BD-Tau) RUO. Le test est disponible sur les plateformes DxI 9000 Immunoassay Analyzer et Access 2 Analyzer.
BD-Tau repr茅sente une avanc茅e significative dans la recherche sur les maladies neurod茅g茅n茅ratives, offrant une sp茅cificit茅 accrue par rapport aux marqueurs tau traditionnels. Le test d茅tecte directement la prot茅ine tau d'origine c茅r茅brale dans le sang, fournissant un indicateur plus pr茅cis de la neurod茅g茅n茅rescence. De plus, la soci茅t茅 a annonc茅 le d茅veloppement d'un immunodosage A尾-42 RUO, franchissant une 茅tape vers la d茅signation Breakthrough Device de la FDA pour un test fond茅 sur le ratio p-Tau217/A尾-42.
Beckman Coulter Diagnostics, ein Unternehmen von Danaher (NYSE:DHR), hat den ersten vollst盲ndig automatisierten Brain-derived Tau (BD-Tau) RUO-Immunoassay f眉r Forschungszwecke auf den Markt gebracht. Der Test ist auf den Plattformen DxI 9000 Immunoassay Analyzer und Access 2 Analyzer verf眉gbar.
BD-Tau stellt einen bedeutenden Fortschritt in der Forschung zu neurodegenerativen Erkrankungen dar und bietet eine verbesserte Spezifit盲t im Vergleich zu herk枚mmlichen Tau-Markern. Der Test detektiert direkt gehirnabgeleitete Tau-Proteine im Blut und liefert so einen pr盲ziseren Hinweis auf Neurodegeneration. Zudem k眉ndigte das Unternehmen die Entwicklung eines A尾-42 RUO-Immunoassays an und macht damit Fortschritte in Richtung einer FDA Breakthrough Device Designation f眉r einen Test basierend auf dem p-Tau217/A尾-42-Verh盲ltnis.
- First fully automated BD-Tau research use only immunoassay test in the industry
- Enhanced specificity compared to traditional tau markers for neurodegenerative research
- Development of A尾-42 RUO test advances progress toward FDA Breakthrough Device Designation
- Automated platform enables consistent results and accelerated regulatory pathways
- None.
Insights
Beckman Coulter's automated BD-Tau test represents a significant advancement for neurodegenerative disease research with improved specificity over existing biomarkers.
Beckman Coulter's launch of the first fully automated Brain-derived Tau (BD-Tau) immunoassay test marks a significant technological advancement in neurodegenerative disease research. The test's key innovation lies in its ability to detect the short form of brain-derived tau directly in blood, offering enhanced specificity compared to existing total tau (t-tau) and phosphorylated tau (p-tau) markers by minimizing interference from peripheral tau sources.
The technical specifications reveal important research applications: BD-Tau has demonstrated a strong correlation with cerebrospinal fluid total tau, particularly when both amyloid-尾 and tau tangle abnormalities are present. This makes it valuable for studying Alzheimer's disease progression, as A尾-positive individuals consistently show higher BD-Tau concentrations. Elevated BD-Tau levels also predict future brain atrophy and cognitive decline, establishing its potential as a predictive biomarker.
From a research methodology perspective, the test's compatibility with Beckman Coulter's DxI 9000 Immunoassay Analyzer and Access 2 Analyzer platforms offers significant workflow advantages through automation. This platform standardization can enhance data consistency across longitudinal clinical trials while reducing manual processing requirements.
The announced development of an A尾-42 immunoassay test further strengthens Beckman Coulter's neurodegenerative testing portfolio, which already includes assays for p-Tau217, NfL, GFAP, and APOE 蔚4. This comprehensive approach positions the company to advance a p-Tau217/A尾-42 ratio test toward FDA submission under their Breakthrough Device Designation, potentially accelerating the pathway from research applications to clinical diagnostics.
This launch represents a significant advancement in blood-based biomarker testing for neurodegenerative conditions. The BD-Tau assay addresses a critical limitation in current tau testing by specifically targeting brain-derived tau isoforms while excluding peripheral tau that can confound results. This improved specificity could substantially enhance research accuracy.
What distinguishes this development is its full automation capabilities on established high-throughput clinical platforms. This integration means researchers can utilize standardized clinical-grade systems rather than research-only platforms, potentially accelerating translation from research to clinical practice. The workflow efficiency gained through automation cannot be overstated 鈥� it reduces manual processing errors, improves reproducibility, and enables higher testing volumes crucial for large-scale clinical studies.
The development pattern here reveals Beckman Coulter's strategic roadmap: they're building a comprehensive neurodegenerative testing ecosystem by methodically expanding their biomarker portfolio (p-Tau217, NfL, GFAP, APOE 蔚4, and now BD-Tau and A尾-42). This approach positions them advantageously against competitors who offer more fragmented solutions.
The announcement of the A尾-42 assay development specifically to support their p-Tau217/A尾-42 ratio test (already granted FDA Breakthrough Device Designation) signals a clear path toward clinical applications. If approved, such tests could fundamentally alter neurodegenerative disease diagnosis by providing accessible blood-based alternatives to more invasive or expensive testing methods like cerebrospinal fluid analysis or PET imaging. This would address significant current diagnostic barriers including cost, accessibility, and patient discomfort.
Beckman Coulter Also Announces Development of A脽-42 Research Use Only Immunoassay Test
BD-Tau, an isoform of brain-derived tau, is emerging as a highly promising blood-based biomarker for neurodegenerative research. Studies across several cohorts reveal a strong relationship between plasma BD-Tau and cerebrospinal fluid (CSF) total tau (t-tau), with this association becoming even more pronounced when both amyloid-尾 (A尾) and tau tangle (N) abnormalities are present. Unlike total tau (t-tau) and phosphorylated tau (p-tau), BD-Tau offers enhanced specificity; by detecting the short form of brain-derived tau directly in the blood, it accurately reflects central nervous system pathology while minimizing confounding factors from peripheral tau sources. This makes BD-Tau a more precise and accessible indicator for neurodegeneration than prior tau markers.
"With the launch of our BD-Tau RUO assay, Beckman Coulter Diagnostics is providing researchers with a critical tool for quantifying tau protein specifically produced by the brain, enabling deeper insights into disease mechanisms," said Dr. Christopher Bird, Chief Medical Officer, Beckman Coulter Diagnostics, and Vice President, Medical Excellence & Disease Leadership for Danaher's Diagnostics business. "Adding to the profound potential to reshape future neurodegenerative clinical practice, accessibility to a BD-Tau RUO marker could revolutionize disease diagnosis, enable timely therapeutic interventions, and provide more accurate assessment of disease progression and treatment efficacy, thereby significantly advancing differential diagnostic capabilities for complex neurological disorders."
Plasma BD-Tau has been shown to closely track with A尾 pathology throughout the Alzheimer's disease (AD) spectrum. Individuals who are A尾 positive (A+) consistently present with higher BD-Tau concentrations than those who are A尾 negative (A鈥�), suggesting its potential for further investigation as a biomarker in AD research, even in the earliest disease stages. Elevated BD-Tau levels in plasma also predict future brain atrophy and cognitive deterioration, linking it not only to current disease burden but also to disease progression. Importantly, combining plasma BD-Tau with phosphorylated tau (p-tau) can support research into the A尾/Neurodegeneration (A/N) framework, potentially enabling more refined research stratification for studying disease risk and exploring personalized research interventions. Notably, research indicates BD-Tau elevation appears to be associated with AD, as levels remain unaltered in studies of non-AD dementias such as frontotemporal dementia (FTD). Its unique profile also suggests it may be a valuable subject for research into stroke, traumatic brain injury (TBI), and potentially other progressive neurodegenerative diseases referred to as tauopathies.
Nick Culshaw, Vice President Clinical Chemistry Immunoassay Innovation, Product and Program Management for Beckman Coulter Diagnostics added, "Complementing its research utility, a fully automated, high throughput BD-Tau RUO Assay offers substantial workflow advantages. Automated assays enhance research efficiency by minimizing manual intervention. Additionally, using a fully automated high throughput IVD-cleared diagnostics platform, such as the DxI 9000 analyzer, during clinical trials can assist in achieving consistency of results across long term clinical trials, accelerating regulatory pathways, and facilitating robust data collection for enhanced real-world evidence."
In related news, Beckman Coulter Diagnostics also today announced it is developing an A尾-42 RUO immunoassay test for use on the DxI 9000 and Access 2 analyzers. A尾-42 is widely recognized as a key biomarker in AD diagnostics, playing a crucial role in early detection and understanding of the disease's progression. The availability of this Access A尾-42 RUO assay is a significant step forward in preparation for Beckman Coulter's IVD submission of its p鈥慣au 217/A尾-42 ratio test to the
The development of the new BD-Tau and A尾-42 RUO assays underscores Beckman Coulter Diagnostics' commitment to developing a .
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About Beckman Coulter. Inc.
A global leader in advanced diagnostics, 聽has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time 鈥� 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 optimize 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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Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Our businesses partner closely with customers to solve many of the most important health challenges impacting patients around the world. Danaher's advanced science and technology - and proven ability to innovate - help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop and deliver life-changing therapies. Focused on scientific excellence, innovation and continuous improvement, our 63,000 associates worldwide help ensure that Danaher is improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. Explore more at聽www.danaher.com.
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