Roche’s Blood Test for Alzheimer’s Wins European Approval

Roche announced Tuesday that its Elecsys pTau217 blood test, developed with Eli Lilly, has received CE Mark approval for use in the European Union, making it the first blood test designed to signal and rule out Alzheimer’s disease.

Roche Diagnostics CEO Matt Sause called the approval a significant step toward earlier diagnosis. Alzheimer’s is the most common cause of dementia, and in the EU, cases among those over 60 have risen from 5.9 million in 2000 to an estimated 9.1 million in 2018, with projections of 13.4 million by 2030.

The test detects high levels of pTau217 protein, a strong indicator of amyloid plaques in the brain associated with Alzheimer’s. A negative result can spare patients from invasive procedures like spinal taps or brain scans.