Roche receives CE Mark for blood test to help rule out Alzheimer’s
Ella Day | July 30, 2025 | News story | Research and Development | Alzheimer's disease, CE Mark approval, Eli Lilly, Neurology, Roche
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in vitro diagnostic regulation-certified blood-based diagnostic designed to help rule out Alzheimer’s-associated amyloid pathology. Developed in collaboration with Eli Lilly, the test is a minimally invasive tool to support earlier and more accessible diagnosis of Alzheimer’s disease.
Elecsys pTau181 measures levels of phosphorylated Tau 181 (pTau181), a biomarker which has been linked to Alzheimer’s. Clinicians can use the test alongside other clinical information to identify patients unlikely to have Alzheimer’s as the cause of cognitive decline – potentially avoiding the need for more invasive and expensive procedures such as positron emission tomography (PET) scans or cerebrospinal fluid analysis.
“With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline,” said Matt Sause, CEO of Roche. “This test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.”
The approval is supported by an international clinical study across the US, Europe and Australia. Results showed the test achieved a 93.8% negative predictive value and 83.6% sensitivity, with minimal influence from patient factors like age or kidney function.
Roche is also furthering its Alzheimer’s diagnostics pipeline with Elecsys pTau217, another blood-based assay showing promise for broader clinical adoption.
Ella Day
30/7/25
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