Beckman Coulter Diagnostics Debuts High Throughput BD-Tau Immunoassay Test

Beckman Coulter Diagnostics, a Danaher company, has launched the industry’s first fully automated brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test.

Access BD-Tau, along with Beckman Coulter Diagnostics’ portfolio of neurodegenerative disease RUO assays, is available for use on the company’s DxI 9000 Immunoassay Analyzer and Access 2 Analyzer. This assay lineup enables precision medicine research on clinical-grade platforms for various neurodegenerative diseases and includes p‑Tau217, NfL, GFAP, and APOE ε4.

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-β (Aβ) 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 Aβ pathology throughout the Alzheimer’s disease (AD) spectrum. Individuals who are Aβ positive (A+) consistently present with higher BD-Tau concentrations than those who are Aβ negative (A–), 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 Aβ/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 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.

“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,” stated Nick Culshaw, vice president of Clinical Chemistry Immunoassay Innovation, Product, and Program Management for Beckman Coulter Diagnostics. “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.”

Beckman Coulter Diagnostics also is developing an Aβ-42 RUO immunoassay test for use on the DxI 9000 and Access 2 analyzers. Aβ-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 Aβ-42 RUO assay is a significant step forward in preparation for Beckman Coulter’s IVD submission of its p‑Tau 217/Aβ-42 ratio test to the U.S. Food and Drug Administration as part of its previously received Breakthrough Device Designation.

An advanced diagnostics developer, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Its diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories, and physician office settings worldwide. The company accelerates 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 family of global science and technology companies. Headquartered in Brea, Calif., it employs more than 11,000 workers.

Danaher is a global life sciences and diagnostics innovator that accelerates science and technology to improve human health. Its advanced science and technology help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop, and deliver life-changing therapies. The company employs 63,000 associates worldwide.