Roche's pTau217 Blood Test Receives CE Mark for Use in Europe

Roche announced the clearance of Elecsys pTau217 on Tuesday after the blood test received the CE Mark. The CE Mark confirms the safety and performance of Elecsys pTau217 and allows its use in the European Union. Elecsys pTau217 is the first blood test designed to signal and rule out Alzheimer’s disease.

The blood test was developed in collaboration with Eli Lilly and Company. According to Roche, Elecsys pTau217 offers faster diagnosis for millions of patients worldwide. It is intended for use across both primary and secondary care settings.

A positive Elecsys pTau217 test result means there are high levels of the pTau217 protein, a strong signal that amyloid plaques are likely present in the brain. A negative Elecsys pTau217 test result indicates that Alzheimer’s is unlikely and can prevent further invasive tests such as spinal fluid or brain scans.

This allows general practitioners to refer patients to specialists already equipped with useful data for a faster diagnosis.

Matt Sause, CEO of Roche Diagnostics, said the launch addresses a major gap in care. “The launch of pTau217 marks a significant step in providing a simple, blood-based tool to diagnose Alzheimer's much earlier in the patient journey,” he stated. Sause added that many people today face a long and difficult path to a diagnosis, often relying on specialised care and costly procedures.

“By bringing this advanced test into routine care, we are helping physicians to support patients and families with an earlier assessment that is critical for timely intervention, while reducing pressure on healthcare systems,” Sause noted. Euronews reported that the test’s availability could reshape how Alzheimer’s is assessed across Europe.

Carole Ho, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, emphasised the human stakes.

“For millions of families navigating the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward meaningful care,” she said. Alzheimer’s is the most common cause of dementia, accounting for 60 to 80% of the cases. 1 million in 2018, according to the Organisation for Economic Co-operation and Development.

7 million by 2050. These figures underscore the growing burden the new test seeks to address through earlier and less invasive assessment.