Roche Gets EU Approval For Alzheimer’s Blood Test

Brussels: (Web Desk) –  Swiss pharmaceutical company Roche has announced that it has received regulatory approval in the European Union to market a new blood test designed for the early detection of Alzheimer’s disease.

The test, named Elecsys pTau217, was developed in collaboration with US-based laboratory partner Eli Lilly. It works by identifying abnormal protein changes in the blood that are linked to the development of neurodegenerative conditions such as Alzheimer’s disease.

According to the company, the test has received the “CE” marking, confirming that it meets European health, safety, and environmental standards required for medical use in the EU.

Roche said the new blood-based method is significantly easier and less invasive compared to traditional diagnostic procedures, which often require spinal fluid samples.

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Matt Sause, chief executive of Roche Diagnostics, described the approval as an important milestone, saying it represents “a significant step” toward enabling earlier diagnosis of Alzheimer’s disease.

He added that integrating the test into routine clinical practice would help doctors provide earlier assessments, allowing patients and families to access timely care and intervention.

Roche noted that Alzheimer’s disease remains the most common form of dementia, and current diagnosis can take an average of three and a half years, highlighting the need for faster and more accessible testing methods.