New Blood Test for Alzheimer’s Gets Green Light in Europe

Finally, a bit of good news for anyone who has watched a loved one navigate the long, frustrating maze of Alzheimer’s diagnosis. A Swiss drugmaker has just secured permission to sell a blood test across Europe that aims to detect or rule out the disease, potentially saving patients from the usual battery of spinal taps and expensive brain scans.

Roche announced on Tuesday that its test, called Elecsys pTau217, has received the CE Mark. That label essentially means European regulators are satisfied that it’s safe and works as advertised. The test is the first of its kind designed specifically for Alzheimer’s, and it didn’t get here alone – Roche developed it in partnership with Eli Lilly.

According to the company, this tool could speed up the diagnostic process for millions globally. A top executive at Roche Diagnostics, Matt Sause, was quoted as saying that the launch is a meaningful step toward a simple blood-based method for spotting Alzheimer’s much earlier. He also noted that too many people currently endure a long and difficult road to a diagnosis, one that often relies on expensive specialist procedures. Bringing this test into everyday care, he argued, would help doctors support families with earlier assessments while also easing the burden on healthcare systems.

For those unfamiliar, Alzheimer’s is the leading cause of dementia, responsible for somewhere between 60% and 80% of all cases. The numbers are only climbing. Data from the OECD shows that in the European Union, the number of people over 60 living with dementia grew from 5.9 million in 2000 to roughly 9.1 million in 2018. Those same estimates project 13.4 million cases by 2030, and a staggering 18.7 million by 2050.

An executive vice president at Eli Lilly, Carole Ho, was also cited as saying that for families dealing with the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward proper care.

So how does this wonder-test actually work? The Elecsys pTau217 is designed for use in both primary and secondary care settings. That means a general practitioner could run the test and, if needed, send a patient to a specialist already armed with useful data. A positive result points to high levels of a protein called pTau217, which itself is a strong signal that amyloid plaques – those abnormal protein clumps linked to Alzheimer’s – are likely present in the brain. A negative result, on the other hand, suggests Alzheimer’s is probably not the culprit and could save patients from undergoing invasive follow-ups like spinal fluid collection or brain imaging.

It sounds clean and simple. Then again, the hard part was never the needle. It’s what happens after the result arrives.

Written by Sandy van Dongen