FREMONT, Calif., Oct. 10, 2025 /PRNewswire/ — Alamar Biosciences, a leader in precision proteomics, today announced the launch of NULISAqpcr™ BD-pTau217 Assay, a blood-based test designed for the quantification of brain-derived phosphorylated tau-217 (pTau217), a critical biomarker for Alzheimer’s disease and other tauopathies. This first-of-its-kind, brain-specific assay offers unmatched sensitivity and specificity from non-invasive sample types such as plasma, serum, and dried blood spots, eliminating the need for cerebrospinal fluid sampling or PET imaging.
Science Significance
Alzheimer’s disease remains a major unmet need in neurodegenerative research, with early detection critical for intervention and therapy evaluation. The NULISAqpcr BD-pTau217 Assay provides a single-plex, brain-specific measurement of CNS-derived tau, significantly reducing background noise from peripheral tau sources. Dr. Yuling Luo, founder and CEO of Alamar Biosciences, stated, “The NULISAqpcr BD-pTau217 test redefines what is possible in the quantification of CNS biomarkers, enabling researchers to detect meaningful brain changes earlier and with greater accuracy.” Independent evaluation by Jonathan Schott, MD, PhD, Professor of Neurology at University College London, confirmed that the single-plex brain-specific assay demonstrates higher fold change and fewer indeterminate results compared to conventional plasma pTau217 tests, providing a robust tool for detecting asymptomatic individuals at high risk of Alzheimer’s pathology. Built on the proprietary NULISA™ platform, the assay achieves single digit attomolar sensitivity, enabling detection of minute biomarker levels. The platform can be deployed as a standalone NULISAqpcr assay or as part of the NULISAseq™ CNS Disease Panel 120 multiplex panel, supporting both discovery and translational research.
Regulatory Significance
Although the BD-pTau217 Assay is for research use only and not intended for clinical diagnostics, it represents an important regulatory milestone in enabling biomarker-driven research. Non-invasive, high-throughput assays such as this can accelerate the development of disease-modifying therapies by providing robust, reproducible biomarker data for clinical trials. The automated ARGO™ HT system allows processing of over 220 samples per day, making it suitable for population studies and large disease cohorts, and supports data generation in line with regulatory expectations for biomarker validation.
Business Significance
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The launch reinforces Alamar Biosciences’ position as a pioneer in ultra-sensitive proteomics and CNS biomarker research. By offering a first-in-class, brain-specific blood assay, Alamar strengthens its footprint in neuroscience research, clinical translational studies, and high-throughput proteomics applications. Strategic collaborations with the neuroscience community and ongoing projects with organizations such as the Alzheimer’s Disease Data Initiative demonstrate Alamar’s ability to integrate its assay platform into global research networks. The commercial availability of BD-pTau217 also positions the company for potential future partnerships with biopharma companies developing disease-modifying Alzheimer’s therapies, offering a tool for trial enrichment and biomarker monitoring.
Patients’ Significance
For patients and at-risk populations, early detection of Alzheimer’s disease is critical for intervention and clinical trial participation. Traditional diagnostic approaches—CSF sampling or PET imaging—are invasive, costly, and not widely accessible. The NULISAqpcr BD-pTau217 assay allows a simple blood draw to detect brain-specific tau, increasing accessibility for research studies and potentially accelerating patient stratification for emerging therapies. By facilitating longitudinal monitoring of CNS biomarkers, this assay enables researchers to track disease progression and evaluate responses to novel treatments more effectively, ultimately benefiting patient outcomes in both clinical trials and translational research programs.
Policy Significance
The assay highlights the growing role of precision proteomics in public health policy and translational neuroscience. Policymakers and funding agencies are increasingly prioritizing biomarker-driven early detection strategies to reduce the burden of neurodegenerative disease and improve population-level research outcomes. By providing a scalable, high-throughput, non-invasive research tool, Alamar Biosciences supports initiatives aimed at earlier intervention, personalized medicine, and data-driven strategies for Alzheimer’s prevention and treatment.
Transaction Highlights
The launch of Alamar Biosciences’ NULISAqpcr™ BD-pTau217 Assay represents a major advancement in precision proteomics and CNS biomarker research. As the first brain-specific single-plex blood assay for pTau217, it delivers unmatched sensitivity and specificity, enabling researchers to detect Alzheimer’s-related pathology earlier and more accurately than conventional plasma tests. The assay can also be integrated into the NULISAseq™ CNS Disease Panel 120 multiplex format and is fully automated using the ARGO™ HT system, allowing high-throughput processing of more than 220 samples per day. These capabilities support longitudinal studies, population-based research, and translational neuroscience programs. Combined with Alamar’s proprietary NULISA™ platform and ongoing global collaborations, the launch strengthens the company’s leadership in early disease detection and accelerates biomarker discovery, ultimately facilitating the development of disease-modifying therapies.
Source: Alamar Biosciences, Inc Press Release
