Beckman Coulter Diagnostics launches industry first fully automated, high throughput BD-Tau research use only immunoassay test
Beckman Coulter Diagnostics, a Danaher company 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' expanding portfolio of neurodegenerative disease RUO assays, is available for use on the groundbreaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer. 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.
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.
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.
In related news, Beckman Coulter Diagnostics also announced it 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.
