Summary:
ALZpath, Inc. announced that data from evaluations of its proprietary pTau217 antibody for blood-based Alzheimer’s diagnostics was presented at the 2025 AD/PD Conference, reinforcing its potential for early detection and treatment advancements.
Key Takeaways:
- ALZpath’s pTau217 antibody enables highly sensitive blood-based detection of a key Alzheimer’s biomarker, supporting early diagnosis before symptoms appear.
- Diagnostic assays incorporating pTau217 are advancing toward clinical use, with some receiving FDA breakthrough device designation.
- Widespread adoption of these blood tests could improve Alzheimer’s diagnosis, treatment access, and disease monitoring while reducing reliance on invasive procedures.
ALZpath, Inc., a developer of diagnostic tools and solutions for Alzheimer’s disease and related dementias, has announced the inclusion of data from evaluation of blood testing platforms utilizing its proprietary pTau217 antibody in several high-impact presentations at the recent 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD). The data is based on recent studies conducted by industry leaders, including Beckman Coulter Diagnostics, Bio-Techne, and Neurocode.
Alzheimer’s disease and related dementias are expected to impact nearly 153 million people globally by 2050. With the increase of cases and emergence of disease-modifying therapies, there is a greater and more urgent need for widespread, rapid, and accessible diagnostic testing.
pTau217 Antibody Identifies Key Alzheimer’s Biomarker
ALZpath’s proprietary pTau217 antibody enables highly sensitive and accurate blood-based detection of phosphorylated tau at position 217 (pTau217), a key Alzheimer’s disease biomarker, supporting early-stage diagnosis well before symptoms appear. In addition, these blood tests can enable early patient identification, treatment qualification, and response monitoring, while building robust evidence to validate new therapies.
Assays incorporating the ALZpath pTau217 biomarker are in development for clinical (IVD) use, including distinct tests with breakthrough device designation from the FDA being advanced by Beckman Coulter Diagnostics and Roche. Other assays containing the ALZpath antibody are already in widespread use in research settings on testing platforms from Alamar Biosciences, Bio-Techne, and Quanterix, as well as in world-class laboratories such as Neurocode.
Enhancing Alzheimer’s Diagnosis & Treatment
Broadened availability of advanced blood-based assays utilizing ALZpath pTau217 antibody in research and clinical settings may significantly enhance Alzheimer’s disease diagnosis and treatment by improving access to accurate and early detection and interventions, enabling risk stratification and monitoring of disease progression, and reducing reliance on other more invasive and costly tests.
“This data highlights the importance of ALZpath’s pTau217 antibody in transforming Alzheimer’s disease diagnosis and treatment, making early detection more accessible as demand continues to rise,” said Mike Banville, CEO of ALZpath. “These studies further validate that researchers and clinicians equipped with tests that include our antibody will be better equipped to identify Alzheimer’s disease before symptoms appear and the disease has progressed significantly, leading to more timely interventions and improved patient outcomes.”
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