Fujirebio announced the publication of a landmark study in Brain (Oxford Academic): “Plasma pTau 217/Aβ 1-42 Ratio for Enhanced Accuracy and Reduced Uncertainty in Detecting Amyloid Pathology.”
The study reflects a collaborative effort between co-authors and Fujirebio to scientifically and clinically evaluate plasma biomarkers for Alzheimer’s disease (AD), and to identify an optimal biomarker combination, culminating in the development of the Lumipulse® G pTau217/β-Amyloid 1-42 Plasma Ratio.
The key findings were:
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Improved detection using the pTau217/β-Amyloid 1-42 Plasma Ratio—combining plasma pTau 217 and Aβ 1-42 into a ratio significantly enhances diagnostic performance compared to pTau 217 alone, reducing indeterminate results and improving confidence in detecting amyloid pathology.
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A rigorous, clearly described approach to clinical cutoff determination—thresholds were derived using both cerebrospinal fluid (CSF) biomarkers and amyloid positron emission tomography (PET) imaging, ensuring alignment with real-world clinical practice for symptomatic patients.
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Enabling appropriate implementation—the study’s findings underscore that biomarker cutpoints should be considered within an assay-specific and population-specific context, with careful attention to the reference comparator and statistical approach, highlighting the importance of clear frameworks and independent validation before broader application.
Blood-based biomarkers (BBM) are transforming AD diagnostics by offering less invasive, more accessible tools for identifying amyloid pathology. Fujirebio’s findings support the clinical value of combining complementary biomarkers to capture distinct aspects of disease pathology, paving the way for more accurate and confident diagnoses in secondary care settings.
“What’s exciting here isn’t just the development of a new biomarker, but it’s the clinically grounded way the thresholds were built and validated, using real-world comparators (PET and CSF) and a two-cutoff approach that reduces ‘indeterminate’ results. That means, more patients get accurate results, that clinicians can trust and act on. Many families just want clarity without months of waiting or an invasive spinal tap or an expensive PET scan. This FDA-cleared blood test can help us determine, more quickly and more comfortably, whether Alzheimer’s amyloid pathology is likely, so patients can get to the right next step sooner.” said Dr. Abhay R. Moghekar, MBBS, Research Director, Cerebrospinal Fluid Center, Department of Neurology—Johns Hopkins School of Medicine, Baltimore, MD.
About Fujirebio
Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust Lumipulse® platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry. Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster— driving better decisions, treatments, and patient outcomes.
Media Contact:
Janet Detwiler, Executive Assistant to the CEO
Fujirebio Diagnostics, Inc.
