Beckman Coulter Introduces Cutting-Edge Research Use Only Assays for Neurodegenerative Disease Research

Original from: Beckman Coulter

Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which are emerging as the most important biomarkers in neurodegenerative diseases research, including interventional clinical trials.

“Advancements in Research Use Only (RUO) assays for neurodegenerative diseases mark a transformative step in the field, offering precise tools to unravel disease mechanisms. These assays enable researchers to detect and quantify biomarkers with exceptional sensitivity and specificity, facilitating a deeper understanding of conditions such as Alzheimer's disease,” said Dr. Nick Ashton, Senior Director, Biomarker Program at Banner Sun Health Research Institute. “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.”

"We are thrilled to introduce our initial set of RUO assays enabling neurodegenerative disease research," said Kathleen Orland, Senior Vice President, General Manager, Clinical Chemistry and Immunoassay for Beckman Coulter Diagnostics. "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-center collaborations to investigate the underlying mechanisms of these devastating conditions.”

To effectively replace current testing modalities, blood-based biomarkers need to demonstrate concordance with amyloid PET and CSF tests.

p-Tau217 (phosphorylated Tau217) is a critical biomarker to detect tau and amyloid pathology. Tau and amyloid pathology refer to 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 AD and in research has shown to distinguish AD from other neurodegenerative disorders. Leveraging the ALZpath p-Tau217 antibody, the new Beckman Coulter Diagnostics assay enables researchers to detect p-Tau217 levels in plasma, providing insights into the formation of tau tangles.

GFAP (Glial Fibrillary Acidic Protein) is a cytoskeletal, intermediate filament protein. While not AD specific, current evidence suggests that detection of increasing GFAP levels in plasma can be used to assess early stages of AD. Furthermore, GFAP may help distinguish AD dementia from other neurodegenerative diseases.i GFAP levels can also act as a marker for 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 neurodegeneration, regardless of cause. Elevated levels of NfL in cerebrospinal fluid and blood are associated with several neurodegenerative conditions,ii including AD and Parkinson’s disease, and may 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. Beckman Coulter Diagnostics’ new APOE ε4 immunoassay offers >99% concordance with PCR genotypingiii in only 20 minutes, allowing researchers to explore the genetic underpinnings of neurodegenerative disease risks and patient outcomes without having to resort to costly and time-consuming molecular diagnostics.

These neurogenerative RUO assays are all immediately available for use on the DxI 9000 Immunoassay Analyzer, featuring the proprietary Lumi-Phos PRO substrate that enables development of high-sensitivity assays, to support evolving healthcare needs. Additionally, GFAP, NfL, and ApoE4 ε4 assays are also available for use on the Access 2 Immunoassay Analyzer.

Source: Beckman Coulter Introduces Cutting-Edge Research Use Only Assays for Neurodegenerative Disease Research