First fully automated, high throughput BD-Tau immunoassay launched

Access BD-Tau, along with Beckman Coulter Diagnostics' expanding portfolio of neurodegenerative disease RUO assays, is available for use on the Dxl 9000 Immunoassay analyser (pictured) and Access 2 analyser. This portfolio of assays enables precision medicine research on clinical-grade platforms for a variety of neurodegenerative diseases and includes p‑Tau217, NfL, GFAP and APOE ε4.

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio 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-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.

"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 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 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.