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Beckman Coulter Diagnostics Launches Industry First Fully Automated, High Throughput BD-Tau Research Use Only Immunoassay Test, Advancing Neurodegenerative Clinical Research
Prnewswire· 2025-09-10 12:31
Core Insights - Beckman Coulter Diagnostics has launched the first fully automated Brain-derived Tau (BD-Tau) research use only (RUO) immunoassay test, enhancing precision medicine research for neurodegenerative diseases [1][4] - The U.S. FDA has granted Breakthrough Device Designation to Beckman Coulter's Access pTau217/-Amyloid 1-42 plasma ratio Test, indicating its potential significance in clinical diagnostics [2][6] Group 1: Product Launch and Features - The BD-Tau RUO assay is designed for use on the DxI 9000 Immunoassay Analyzer and Access 2 Analyzer, contributing to a portfolio that includes other neurodegenerative disease assays like pTau217, NfL, GFAP, and APOE 4 [1][6] - BD-Tau is identified as a promising blood-based biomarker for neurodegenerative research, showing a strong correlation with cerebrospinal fluid total tau levels, particularly in the presence of amyloid and tau tangle abnormalities [3][4] - The automated BD-Tau assay offers workflow advantages by minimizing manual intervention, thus enhancing research efficiency and consistency in clinical trials [5] Group 2: Clinical Implications and Research Potential - Elevated plasma BD-Tau levels are associated with Alzheimer's disease (AD) pathology, indicating its potential as a biomarker for early detection and monitoring of disease progression [4][6] - The combination of plasma BD-Tau with phosphorylated tau (p-tau) may refine research stratification for studying disease risk and personalized interventions in neurodegenerative diseases [4][5] - The development of the A-42 RUO immunoassay test further supports Beckman Coulter's commitment to advancing diagnostic solutions for neurodegenerative diseases [5][6]