Beckman Coulter Diagnostics has launched industry's first fully automated Brain-Derived Tau (BD-Tau) Research Use Only (RUO) immunoassay test. Access BD-Tau, along with Beckman Coulter Diagnostics's expanding portfolio of neuro-degenerative disease RUO assays, is available for use on the ground-breaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer. This portfolio of assays enables precision medicine research on clinical-grade platforms for a variety of neuro-degenerative diseases and includes p?Tau217, NfL, GFAP and APOE ε4.

BD-Tau is emerging as a blood-based biomarker for neuro-degenerative research. Studies across several cohorts reveal a strong relationship between plasma BD-Tau and cerebrospinal fluid 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 minimising confounding factors from peripheral tau sources. This makes BD-Tau a more precise and accessible indicator for neurodegeneration than prior tau markers.

Dr Christopher Bird, Chief Medical Officer, Beckman Coulter Diagnostics, and Vice President, Medical Excellence and Disease Leadership for Danaher's Diagnostics business, said, "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. Adding to the profound potential to reshape future neuro-degenerative clinical practice, accessibility to a BD-Tau RUO marker could revolutionise 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 personalised 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 neuro-degenerative diseases referred to as tauopathies.

Nick Culshaw, Vice President—Clinical Chemistry Immunoassay Innovation, Product and Programme Management, 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 minimising manual intervention. Additionally, using a fully automated high throughput IVD-cleared diagnostics platform, such as the DxI 9000 analyser, 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."