Beckman Coulter Diagnostics has introduced a fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test, aimed at advancing neurodegenerative clinical research.
According to the company, this is the industry’s first fully automated BD-Tau RUO immunoassay test.
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This new test is available for use on the DxI 9000 Immunoassay Analyser and Access 2 Analyser, alongside a growing range of neurodegenerative disease RUO assays, which include p Tau217, NfL, GFAP, and APOE 蔚4.
Beckman Coulter stated that BD-Tau, an isoform of brain-derived tau, is 鈥渆merging as a highly promising鈥� blood-based biomarker for neurodegenerative research.
Research indicates a correlation between plasma BD-Tau levels and cerebrospinal fluid (CSF) total tau (t-tau), particularly when both amyloid-尾 (A尾) and tau tangle (N) abnormalities are present.
BD-Tau distinguishes itself from total tau and phosphorylated tau by offering enhanced specificity, as it detects the short form of brain-derived tau directly in the blood.
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By GlobalDataIt enables an accurate reflection of central nervous system pathology while reducing confounding factors from peripheral tau sources.
Plasma BD-Tau has been indicated to closely align with A尾 pathology across the entire spectrum of Alzheimer’s disease.
Individuals who test positive for A尾 consistently exhibit higher concentrations of BD-Tau compared to those who are A尾 negative, indicating its potential as a biomarker for Alzheimer’s research, even in the earliest stages.
Elevated BD-Tau levels also predict future brain atrophy and cognitive decline, linking the biomarker to both current disease burden and progression.
Furthermore, combining plasma BD-Tau with phosphorylated tau (p-tau) can back research into the A尾/Neurodegeneration (A/N) framework, facilitating more precise stratification in studies of disease risk and personalised research interventions.
Research shows that BD-Tau elevation seems to be linked with the disease, as levels do not change in studies of non-Alzheimer’s dementias such as frontotemporal dementia (FTD).
Its unique profile also indicates that it may be an important area for research into stroke, traumatic brain injury (TBI), and potentially other progressive neurodegenerative diseases called tauopathies, stated the company.
Beckman Coulter Diagnostics chief medical officer and Danaher’s Diagnostics business medical excellence and disease leadership vice-president Dr Christopher Bird said: 鈥淲ith 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.鈥�
In a related development, the company announced that it is developing an A尾-42 RUO immunoassay test for use on the DxI 9000 and Access 2 analysers.
The forthcoming Access A尾-42 RUO assay marks an advancement in preparation for Beckman Coulter’s submission of its p Tau 217/A尾-42 ratio test to the US Food and Drug Administration (FDA), following its earlier receipt of breakthrough device designation.
In March, the FDA granted 510(k) clearance to Beckman Coulter for its DxC 500i Clinical Analyser, capable of performing up to 800 clinical chemistry tests and 100 immunoassay tests per hour.
