18/07/2025
🔹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.
🔹BioGiox: FDA-Registered p-Tau217 Antibody, Ready for Global IVD Use
In response to this breakthrough, BioGiox has launched a high-performance monoclonal antibody targeting p-Tau217, now officially registered with the FDA under Master File MAF3945, and available for authorized referencing by global IVD developers.
Product Overview:
- Product Name: Anti-pTau217 Monoclonal Antibody
- Catalog Number: KSDM005-06
- FDA Master File No.: MAF3945
- Expression System: CHO cells with Protein A purification
- Available Formats: Unlabeled, HRP-labeled, Biotin-labeled, and custom conjugates
🔹Why Choose BioGiox’s p-Tau217 Antibody?
Trusted by leading IVD developers as a key reagent in AD early detection pipelines.
High specificity for phosphorylated Tau at Thr217
Validated for ELISA, CLIA, and Simoa platforms
CHO expression with Protein A purification for batch consistency
Available in unlabeled, HRP-conjugated, and biotin-conjugated formats
Full regulatory support: COA, validation data, FDA Master File reference
Launch with Confidence: Our “Precision Starter Program” Is Now Live!
To accelerate your entry into the AD diagnostic market, BioGIOX offers exclusive support through the Precision Starter Program, including:
- Free analytical validation support (valued at $5,000)
- Comprehensive documentation package: COA, IFU, MF reference letter
- Priority supply and allocation
- Flexible OEM/ODM partnership models tailored to your platform
🔹Your One-Stop Source for Neurodegenerative Biomarker Antibodies
BioGiox offers a comprehensive portfolio of reagents for AD and neurodegeneration research and diagnostics:
Tau Family: t-Tau, p-Tau181, p-Tau217, p-Tau205, p-Tau231, BD-Tau
Amyloid-β Family: Pan-Aβ, Aβ-40, Aβ-42
Neuro Markers: GFAP, NFL, α-synuclein
We provide full support from R&D to regulatory submission, enabling rapid validation, commercialization, and global compliance.
🔹Connect with Us
Ready to accelerate your Alzheimer’s diagnostic development? Contact us today for samples, validation data, and Master File reference support:
Erick (Business Development)
- 📩Email: geyunfan@biogiox.com
- 📞WhatsApp: +1 626 567 4430
- 📲Mobile (CN): +86 136 0123 0671
p-Tau217 is not just the future — it’s the present. Partner with BioGiox and lead the new era of Alzheimer’s early detection.
