Health Canada has approved Fujirebio’s Lumipulse G NfL Blood and pTau 217 Plasma assays, expanding access to blood-based neurology biomarkers for clinical use on the Lumipulse G immunoassay platform.
USC researchers report that two blood tests, Lumipulse G p-tau217/β-Amyloid 1-42 and PrecivityAD2, can accurately detect Alzheimer’s pathology in patients with Down syndrome.
The p-Tau217 assay runs on the DxI 9000 Immunoassay Analyzer, enabling laboratories to incorporate blood-based Alzheimer’s biomarker testing into high-throughput workflows.
The agreement will integrate a specific antibody into diagnostic tests for use on widely installed immunoassay systems.
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The system uses routine blood draws to provide results in 17 minutes, offering an alternative to invasive diagnostic methods.
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With the first FDA-cleared test and clinical guidelines debuting since May 2025, labs are evaluating how blood-based biomarkers fit into diagnostic protocols.
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Biomarkers in midlife adults without dementia may be linked to the earliest signs of waning cognition, researchers found.
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Researchers have identified a blood-based biomarker panel that may identify Alzheimer’s disease patients at increased risk for brain swelling or bleeding associated with new anti-amyloid therapies.
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The sensor identifies misfolded protein biomarkers in blood before clinical symptoms of neurodegeneration appear.
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The test uses urinary volatile organic compound patterns and machine learning to aid in the diagnosis of Alzheimer’s disease.
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New research suggests that remote capillary sampling for Alzheimer’s biomarkers correlates with cognitive test performance in older adults.
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Researchers at Mass General Brigham have developed a digital seed amplification assay that detects TDP-43 protein seeds in cerebrospinal fluid, enabling identification of FTLD-TDP, a specific frontotemporal lobar degeneration subtype.
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Lucent Diagnostics and Tempus AI have partnered to integrate blood-based Alzheimer’s biomarker testing into clinical workflows, aiming to expand access and improve detection accuracy for neurologists.
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Roche has received CE mark approval for its Elecsys pTau217 blood test, designed to aid in Alzheimer’s disease diagnosis by detecting amyloid pathology in patients with cognitive decline.
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NeuroVision Imaging has acquired Durin Life Sciences, combining blood-based biomarker tests with retinal imaging and telehealth to advance early detection of Alzheimer’s and Parkinson’s diseases.
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Fujirebio Europe has received CE marking for its automated Lumipulse G pTau 217 Plasma assay, designed to help identify amyloid pathology in patients with cognitive decline, according to the company.
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Research shows the pTau217 biomarker can identify risk for cognitive decline and amyloid buildup before changes appear on brain scans.
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Circular Genomics and Vitazi.ai have formed a partnership to combine AI-driven retinal imaging and blood-based RNA biomarkers for early Alzheimer’s disease detection, aiming to address gaps in early-stage patient identification.
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