Raw Materials for Alzheimer's Diagnostics

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BioGiox Empowers IVD Innovators with High-Performance Antibody Solutions p-Tau217 Ushers in a New Era of Alzheimer's Early Detection.  

Quest Diagnostics has announced plans to incorporate the FDA-approved Alzheimer's disease (AD) blood-based diagnostic test developed by Fujirebio Diagnostics into its laboratory testing services. The assay, officially named Lumipulse^® G pTau 217/β-Amyloid 1-42 Plasma Ratio, is the first blood-based in vitro diagnostic (IVD) test authorized by the U.S. Food and Drug Administration (FDA) to aid in the clinical diagnosis of AD.  

In April 2024, Quest launched its own laboratory-developed test (LDT) targeting the same biomarkers—pTau217 and β-Amyloid 1-42—to assess Alzheimer's-related amyloid pathology. In May 2024, the Lumipulse assay received FDA clearance, marking a major milestone in the clinical adoption of blood-based diagnostics for Alzheimer's disease. The integration of Fujirebio's FDA-approved test now further strengthens Quest's diagnostic portfolio. 

According to the company, the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test will be available in summer 2025, enabling physicians and researchers to assess Alzheimer's-related biomarker ratios using standard plasma obtained from venous blood samples. The test quantifies the plasma ratio of phosphorylated Tau 217 (pTau217) to β-Amyloid 1-42, helping to identify underlying amyloid pathology associated with AD. While cerebrospinal fluid (CSF) testing for these biomarkers is well-established, it requires lumbar puncture, which limits accessibility. In contrast, blood-based testing offers a non-invasive, scalable alternative, opening the door to earlier screening and wider access across diverse healthcare settings 

According to Quest CEO Jim Davis, the test is expected to significantly reduce reliance on PET-CT imaging for Alzheimer's diagnosis over time. This development highlights a broader paradigm shift in Alzheimer's diagnostics: p-Tau217 is emerging as a core molecular biomarker, not only for early detection, but also for patient stratification, clinical trial enrollment, and therapeutic monitoring—a key advancement in the global fight against Alzheimer's disease.