US-based diagnostic systems provider Beckman Coulter Diagnostics has rolled out new Research Use Only (RUO) blood-based immunoassays for neurodegenerative diseases.
The new RUO assays are intended to evaluate p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which play an important role in neurodegenerative disease research.
All four assays are immediately available for use on the DxI 9000 Immunoassay Analyser.
The DxI 9000 system features the company’s Lumi-Phos PRO substrate that enables the development of high-sensitive assays, to support evolving healthcare needs.
In addition, GFAP, NfL, and ApoE4 ε4 assays are also available for use on the Access 2 Immunoassay Analyser.
Beckman Coulter Diagnostics senior vice president, clinical chemistry and immunoassay general manager Kathleen Orland said: “We are thrilled to introduce our initial set of RUO assays enabling neurodegenerative disease research.
“Availability of these assays on our automated, high throughput platforms will fundamentally change workflow, precision, and reliability of biomarker testing for neurodegenerative diseases.
“Our global install base opens new possibilities for multi-centre collaborations to investigate the underlying mechanisms of these devastating conditions.”
According to the company, blood-based biomarkers require concordance with amyloid PET and CSF tests to effectively replace current testing modalities.
The p-Tau217 (phosphorylated Tau217) is a key biomarker for detecting tau and amyloid pathology, the abnormal accumulation of tau and amyloid beta proteins in the brain.
Current evidence shows that plasma p-Tau217 is a sensitive biomarker present through all stages of Alzheimer’s disease (AD) and distinguishes AD from other neuro disorders.
Beckman Coulter’s new assay leverages the ALZpath p-Tau217 antibody to help researchers detect p-Tau217 levels in plasma.
GFAP (Glial Fibrillary Acidic Protein) is a cytoskeletal, intermediate filament protein, whose elevated levels in plasma suggest early stages of AD.
It may help distinguish AD dementia from other neurodegenerative diseases.
Also, GFAP levels can indicate gliosis, a non-specific response to central nervous system damage, in response to neuronal damage from toxins or injury.
NfL (Neurofilament Light Chain) is a key indicator of axonal damage, and its elevated levels in cerebrospinal fluid and blood indicate neurodegenerative conditions.
Also, it can be used for predicting cognitive decline and monitoring treatment efficacy.
APOE ε4 (Apolipoprotein ε4) gene is the most significant genetic risk factor for developing AD, and the new APOE ε4 immunoassay offers more than 99% concordance with PCR genotyping in only 20 minutes.
It allows researchers to explore the underlying genetic link between neurodegenerative diseases and patient outcomes, eliminating molecular diagnostics, said Beckman Coulter.
Banner Sun Health Research Institute biomarker program senior director Nick Ashton said: “Beckman Coulter Diagnostics’ commitment to delivering high-quality RUO assays exemplifies the industry’s dedication to empowering scientists.
“By providing reliable and innovative solutions, they are driving progress toward breakthroughs in early diagnosis, personalized treatment strategies, and ultimately improved patient care.
“Such developments underscore the critical role of cutting-edge technologies in accelerating the path to effective therapies for these challenging diseases.”
