Roche Secures CE Mark for Blood-Based Alzheimer’s Test, Pioneering IVDR-Certified Rule-Out Diagnosis
SHERIDAN, WYOMING – July 25, 2025 – Roche has received CE Mark certification for its Elecsys® pTau181 blood test, marking a pivotal advancement in Alzheimer’s diagnostics by introducing the first IVDR-certified in-vitro diagnostic test to help rule out Alzheimer’s-associated amyloid pathology. Developed in collaboration with Eli Lilly and Company, the test is designed to help clinicians exclude Alzheimer’s disease as the cause of cognitive decline using a simple blood sample, significantly reducing the need for invasive confirmatory procedures like PET scans or CSF analysis.
Minimally Invasive Test Aims to Address Diagnostic Gaps