Novel Blood-Based Assay to Aid in Early Diagnosis and Intervention for Alzheimer's

Recent FDA approvals have marked significant progress in Alzheimer's disease treatments, paving the way for a new generation of therapies. However, the challenge of early Alzheimer's diagnosis remains a key obstacle to the widespread use and accessibility of these treatments. That could now change with a novel, proprietary assay for the blood-based measurement of a highly accurate, diagnostic biomarker for Alzheimer's disease.

ALZpathDx, a proprietary assay developed by ALZpath (Carlsbad, CA, USA), measures phosphorylated tau 217 (pTau217), a highly accurate diagnostic biomarker for Alzheimer's disease. The assay quantifies pTau217 in blood, providing insightful data about brain activity. The biomarker can identify Alzheimer's key indicators in the brain before cognitive symptoms appear. However, the availability of pTau217 tests for research and clinical use is limited. Thus, increasing access to this accurate Alzheimer's disease biomarker is essential for broader evaluation and implementation of Alzheimer's blood tests. Non-invasive tau blood tests like ALZpathDx, capable of accurately measuring specific tau protein levels in the blood, could positively affect patient outcomes through early diagnosis and intervention for Alzheimer's. The assay is conducted on the Quanterix Simoa HD-X immunoassay analyzer.

ALZpath has recently obtained funding from the Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator to expedite ALZpathDx's clinical availability as a laboratory-developed test (LDT). This financial support will allow ALZpath to continue gathering clinical evidence and launch an LDT version of the assay, crucial for timely Alzheimer's detection. Currently, the ALZpath pTau217 assay is available for research use only (RUO) through Quanterix, both as a kit and for services in the Quanterix Accelerator laboratory.

"The Alzheimer's Drug Discovery Foundation has had a transformative impact in advancing the understanding, diagnosis and treatment of Alzheimer's disease," said ALZpath Chief Scientific Officer and principal investigator, Dr. Andreas Jeromin. "Building on that legacy, and with their support, we can now continue expanding our efforts with the goal of ensuring broad clinical availability of ALZpathDx, which will be critical in facilitating timely and accurate detection, as well as providing scalable access to disease-modifying treatments for people living with Alzheimer's."

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