Automated High Throughput Immunoassay Test to Advance Neurodegenerative Clinical Research

Traditional tau and phosphorylated tau measurements can be confounded by peripheral sources, while imaging and cerebrospinal fluid (CSF) testing are invasive or limited in availability. Now, a new immunoassay test aims to advance neurodegenerative clinical research, paving the way for better detection and monitoring of disease progression.

Beckman Coulter Diagnostics (Brea, CA, USA), a Danaher company, has launched the industry’s first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay. Available on the DxI 9000 Immunoassay Analyzer and Access 2 Analyzer, this test joins the company’s portfolio of assays, including p-Tau217, NfL, GFAP, and APOE ε4. By directly detecting the short form of tau produced in the brain, the assay delivers greater specificity and minimizes interference from peripheral tau sources, making it a more precise tool for research.

Research across multiple cohorts has demonstrated a strong relationship between plasma BD-Tau and CSF total tau, particularly in the presence of amyloid-β and tau tangle abnormalities. Plasma BD-Tau concentrations consistently rise in amyloid-positive individuals, and elevated levels have been linked to future brain atrophy and cognitive decline. Importantly, BD-Tau levels remain unaltered in non-Alzheimer’s dementias, highlighting its specificity.

This biomarker shows promise not only for Alzheimer’s research but also for studying other tau-related conditions such as traumatic brain injury (TBI) and stroke. Combining BD-Tau with phosphorylated tau may enhance research stratification in the amyloid/neurodegeneration (A/N) framework, supporting more personalized approaches.

Additionally, Beckman Coulter has developed an Aβ-42 RUO immunoassay, further strengthening its pipeline for comprehensive neurodegenerative diagnostics. Aβ-42 is highly recognized as a key biomarker in Alzheimer’s diagnostics, playing a significant role in early detection and understanding of the disease's progression.

“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."

"Complementing its research utility, a fully automated, high-throughput BD-Tau RUO Assay offers substantial workflow advantages,” added Nick Culshaw, Vice President Clinical Chemistry Immunoassay Innovation, Product and Program Management for Beckman Coulter Diagnostics. “Automated assays enhance research efficiency by minimizing manual intervention. 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."