This past May, the U.S Food and Drug Administration granted approval for the first ever blood test to support diagnosing Alzheimer’s disease – the Lumipulse® pTau217/β-Amyloid 1-42 Plasma Ratio test, developed by Fujirebio Diagnostics. Unlike traditional methods that require PET scans or spinal taps, the simple blood draw offers a less invasive way to detect Alzheimer’s related proteins in the brain.

What makes this a breakthrough?

Alzheimer’s is a progressive condition that affects millions worldwide. A blood test like this could allow for earlier detection, potentially giving people and families more time to plan care and access support services.

In clinical evaluations, the test demonstrated roughly 92% accuracy in identifying Alzheimer’s pathology and 97% accuracy in ruling it out. Such results closely align with PET scan findings.

Although the test isn’t yet available in the UK, researchers here are actively investigating blood-based diagnostics for dementia. The READ-OUT trial, run through the NHS sites, is testing how accurately these blood tests can detect Alzheimer’s and other forms of dementia in real world settings.

This trial aims to make dementia diagnosis faster and more accessible, which could transform care pathways in the future. Blood tests for Alzheimer’s represent a significant step forward in understanding and supporting people living with dementia, both in the UK and internationally.