Beckman Coulter Diagnostics has announced availability of new research use only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research.
The assays will be useful in interventional clinical trials, such as for Alzheimer's disease, according to Beckman Coulter, and are intended to assess four biomarkers:
- Phosphorylated Tau217 (p-Tau217) for detecting tau and amyloid pathology, or the abnormal accumulation of tau and amyloid beta proteins in the brain. Leveraging the ALZpath p-Tau217 antibody, the assay enables researchers to detect p-Tau217 levels in plasma, providing insights into the formation of tau tangles, Beckman Coulter said.
- Glial fibrillary acidic protein (GFAP), a cytoskeletal intermediate filament protein, is not Alzheimer's disease specific; however, current evidence suggests that detection of increasing GFAP levels in plasma can be used to assess early stages of the disease, according to Beckman Coulter.
- Neurofilament light chain (NfL), which is a key indicator of axonal damage and neurodegeneration, Beckman Coulter said, adding that elevated levels in cerebrospinal fluid and blood are associated with several neurodegenerative conditions.
- Apolipoprotein ε4 (APOE ε4), a gene being studied for its role as a significant genetic risk factor for developing Alzheimer's disease.
Beckman Coulter said the four blood-based biomarkers are emerging as the most important biomarkers in neurodegenerative diseases research. The company noted that to effectively replace current testing modalities, blood-based biomarkers need to demonstrate concordance with amyloid positron emission tomography (PET) and cerebrospinal fluid (CSF) tests.
The RUO assays are immediately available for use on the DxI 9000 Immunoassay Analyzer, featuring the Lumi-Phos PRO substrate. Additionally, GFAP, NfL, and ApoE4 ε4 assays are also available for use on the Access 2 Immunoassay Analyzer.
