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
Alzheimer’s disease remains notoriously underdiagnosed, with up to 75% of symptomatic individuals going undetected and diagnosed, on average, nearly three years after symptom onset. Existing diagnostic methods such as PET imaging and lumbar punctures are costly, invasive, and often inaccessible. By providing an accessible alternative, Elecsys pTau181 could transform early-stage Alzheimer’s care.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics. “With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.”
Clinical Study Validates High Diagnostic Accuracy
The CE Mark was granted based on a prospective, multicentre clinical study involving 787 participants across the U.S., Europe, and Australia. The study demonstrated a high negative predictive value (NPV) of 93.8% for the Elecsys pTau181 test, with a sensitivity of 83.6%, based on a 22.5% prevalence of amyloid pathology determined via PET scans.
Key highlights of the study include:
- High diagnostic confidence across primary care and specialist settings
- Rule-out performance unaffected by age, gender, BMI, or kidney function
- Study population aged 55–80, representing diverse ethnic and geographic backgrounds
This was the first diagnostic registrational study of its kind to investigate performance in such a heterogeneous and clinically relevant population, setting a new standard in real-world diagnostic validation.
Strategic Role in Alzheimer’s Disease Management
The Elecsys pTau181 test offers potential to reshape diagnostic workflows by enabling:
- Earlier identification of patients needing further investigation
- More timely access to disease-modifying therapies
- Reduced reliance on invasive diagnostic procedures
- Tailored care pathways based on biomarker evidence
With the growing availability of Alzheimer’s treatments effective in early-stage disease, early biomarker testing will be essential in guiding therapeutic decisions.
Pipeline Progress: Elecsys pTau217 in Development
Roche is also advancing the Elecsys pTau217 test, which has shown strong accuracy and sample stability in detecting amyloid pathology. With its automated high-throughput processing and scalable assay platform, pTau217 is positioned to complement or eventually enhance current biomarker-based diagnostics in routine care.
Commitment to a Multi-Pronged Alzheimer’s Strategy
Roche continues to invest in a broad portfolio of diagnostics and therapeutics addressing Alzheimer’s across its stages. Its offerings span investigational monoclonal antibodies like trontinemab, along with CSF assays, digital tools, and blood-based diagnostics.
The company emphasizes that overcoming Alzheimer’s requires collaboration across science, healthcare systems, and society. “With more than two decades of scientific research in Alzheimer’s disease,” Roche stated, “we are working towards a day when we can detect and treat the disease early, in order to stop or even prevent its progression to preserve what makes people who they are.”
Learn more at www.roche.com