Roche receives CE marking for Alzheimer's blood test

A new blood test that could help detect Alzheimer’s disease earlier has been approved for use in the UK and Ireland, Roche announced today.

The Elecsys® pTau217 test is designed to identify and measure phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease. It is the first blood test intended to help both confirm and rule out the disease across primary and secondary care for people experiencing memory problems or other symptoms of cognitive decline, supporting earlier, faster diagnosis.

In the UK, around one million people are living with dementia, with numbers expected to rise significantly in the coming years. Yet around one in three people remain undiagnosed, and many wait years after symptoms first appear before receiving answers.

Peter Hampson, Head of Medical Affairs at Roche Diagnostics, said the approval marked an important step forward.

“Alzheimer’s remains one of the greatest and most urgent health challenges we face today, affecting millions of people and placing growing pressure on families and health systems. With no cure currently available, earlier and more accurate diagnosis is increasingly critical.

“For many people, the journey to a diagnosis can be long, distressing, and filled with uncertainty. People shouldn’t be left in limbo for months or years, not knowing what’s happening to them. This blood test could help people get answers sooner, when it really matters.”

How the test works

The Elecsys® pTau217 test measures a protein in the blood linked to amyloid - a key hallmark of Alzheimer’s disease. A positive result indicates a high likelihood of amyloid pathology, while a negative result suggests it is unlikely, helping clinicians decide on next steps.

Currently, diagnosing Alzheimer’s often involves brain scans or cerebrospinal fluid tests, which can be costly, invasive, and difficult to access. By contrast, this test uses a simple blood sample, offering a more convenient and minimally invasive alternative while maintaining comparable accuracy to existing methods.

The test can be run on Roche systems already in use in hospitals across the UK and Ireland, supporting the potential for broader, rapid access in clinical settings.

Looking ahead

Earlier detection can help people and their families better understand the cause of symptoms, access appropriate support, and plan for the future. It may also enable access to treatments designed to slow disease progression, which are currently being re-reviewed for NHS use in England by the National Institute for Health and Care Excellence (NICE).

More information about our biomarker technology for Alzheimer's disease testing will be available soon. In the meantime, please visit this page to learn more.