The eMTBR-Tau assay measures tau tangle pathology in blood, with potential applications in Alzheimer’s disease staging, clinical trials, and therapy monitoring.
Alamar Biosciences has launched the first commercial eMTBR-Tau immunoassay, a blood-based test designed to measure tau tangle pathology in Alzheimer’s disease.
The assay is available in the NULISAseq Neuro 220 multiplexed panel kits for use on the ARGO HT instrument base and as a single-plex assay through the company’s Technology Access Program. The eMTBR-Tau biomarker specifically reflects tau tangle pathology and has shown associations with cognitive decline, clinical disease staging, and therapeutic response monitoring.
The company states in a release that while a definitive diagnosis of Alzheimer’s disease requires evidence of both amyloid plaques and tau neurofibrillary tangles, previous blood tests like pTau-217 only indicated amyloid pathology. The company says a positive pTau-217 result alone is often insufficient for a confirmatory diagnosis because many individuals with amyloid accumulation have not yet developed tau tangles.
“eMTBR-Tau is emerging as one of the most important biomarkers in Alzheimer’s disease,” says Yuling Luo, founder, CEO, and chair of Alamar Biosciences, in a release. “We believe the ability to measure tangle-specific tau pathology in combination with other neurodegeneration and neuroinflammation biomarkers from blood, with the sensitivity and specificity that NULISA provides, will open new possibilities in clinical research and clinical trials for disease staging, patient stratification, therapy response monitoring and, ultimately, for precision medicine.”
Historically, measuring tau tangle burden required tau positron emission tomography (PET) imaging, a method that is accurate but expensive and operationally complex. Alamar Biosciences says that recent studies have demonstrated that blood-based eMTBR-tau assays correlate strongly with tau tangle burden, making them a potential surrogate for PET imaging.
The NULISA platform targets the MTBR fragment generated by endogenous cleavage at site 256. The assay measures eMTBR-Tau at attomolar sensitivity and can be multiplexed with other neurodegeneration and neuroinflammation biomarkers from a single low-volume sample. Beyond diagnosis, the association between eMTBR-Tau levels and tau tangle burden may allow researchers to measure biological responses to tau-targeted therapies.
“eMTBR-Tau is a vital addition to the blood-based biomarker toolkit,” says Nicholas Ashton, PhD, senior director of the Fluid Biomarker Laboratory at Banner Health, in a release. “The ability to easily measure tau tangle pathology from a blood draw enables better disease classification and staging and has the potential to be transformative to advancing the development of new therapies for the treatment of Alzheimer’s disease.”
Alamar Biosciences plans to present data regarding the assay’s analytical performance and correlation with PET imaging at the Alzheimer’s Association International Conference in London on July 14.
