Statement from the Alzheimer’s Drug Discovery Foundation (ADDF) on FDA Approval of the First Blood Test to Aid in Alzheimer’s Diagnosis

Today, the FDA’s approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marking a pivotal moment in the fight against Alzheimer’s disease. This is the first blood test authorized to aid in the diagnosis of Alzheimer’s—ushering in a new era of care, alongside recent approvals of disease-modifying therapies.

“Today’s approval is a transformative moment for patients, clinicians, and the field,” said Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “Blood tests for Alzheimer’s are bringing us closer to the goal of an early and accessible diagnosis for all patients—something that was unimaginable just a few years ago. The regulatory approval of the Lumipulse test validates years of scientific progress and collaboration, a core tenet of the ADDF’s Diagnostics Accelerator, and we’re proud to have played a role in advancing this achievement.”

This breakthrough was supported in part by the Diagnostics Accelerator (DxA), a flagship initiative of the ADDF launched in partnership with leading philanthropists including Leonard A. Lauder, Bill Gates, Jeff Bezos, and others. The DxA is dedicated to fast-tracking the development of biomarkers and diagnostics for Alzheimer’s, such as blood tests, retinal scans and digital tools—crucial for improving diagnosis, guiding treatment decisions, and accelerating drug development. To date, the DxA has invested over $90M into nearly 70 projects.

The Lumipulse test represents a minimally invasive, cost-effective tool that can be deployed in a wide range of clinical settings, including primary care. By accurately identifying patients at high risk for Alzheimer’s, it enables earlier and more equitable access to specialist evaluation and treatment—when interventions may be most effective in slowing or even preventing cognitive decline.

Importantly, blood biomarkers are paving the way for precision medicine in Alzheimer’s by enabling more targeted treatment approaches, including combination therapies that address the multiple underlying causes of the disease.

“This is just the beginning,” added Dr. Fillit. “As blood-based biomarkers continue to evolve, they will fundamentally reshape the landscape of Alzheimer’s care, creating a new landscape where precision medicine and prevention of the disease are possible.”