Swiss pharmaceutical company Roche has received European approval for a blood test that can detect and rule out Alzheimer’s disease, offering a simpler and less invasive alternative to current diagnostic methods.
Elecsys pTau217 is the first blood test designed to signal and rule out Alzheimer’s disease, and has now been cleared for use in Europe, Roche announced on Tuesday.
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The blood test, developed in collaboration with Eli Lilly and Company, received the CE Mark – confirming its safety and performance, and allowing its use in the European Union.
According to the Swiss pharmaceutical company, this test offers faster diagnosis for millions of patients worldwide.
“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,” said Matt Sause, CEO of Roche Diagnostics.
He 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.
Alzheimer’s is the most common cause of dementia, accounting for 60 to 80% of the cases.
In the European Union, the prevalence of dementia in people over 60 grew from 5.9 million in 2000 to about 9.1 million in 2018, with estimates of 13.4 million by 2030 and around 18.7 million by 2050, according to the Organisation for Economic Co-operation and Development (OECD).
“For millions of families navigating the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward meaningful care,” said Carole Ho, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience.
How does the test work?
Elecsys pTau217 is intended for use across both primary and secondary care settings, allowing general practitioners to refer patients to the specialist, if needed, already equipped with useful data for a faster diagnosis.
A positive test result means there are high levels of the pTau217 protein, a strong signal that amyloid plaques – abnormal protein build-up associated with Alzheimer's – are likely present in the brain.
A negative result indicates that Alzheimer’s is unlikely, and can prevent further invasive tests, such as spinal fluid or brain scans.
