Roche has received CE Mark for its Elecsys® pTau181 test, developed in collaboration with Eli Lilly and Company. This blood-based assay measures phosphorylated Tau (pTau181), a key biomarker associated with amyloid pathology, a hallmark of Alzheimer’s disease.
Designed to be used alongside clinical assessment, the test enables clinicians to confidently rule out Alzheimer’s as the cause of cognitive decline, potentially eliminating the need for invasive or expensive confirmatory tests like cerebrospinal fluid (CSF) analysis or PET scans in patients who test negative.
“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 Diagnostics. “By enabling earlier and less invasive diagnosis, this test can improve patient outcomes and reduce healthcare costs globally.”
Despite the rising global burden of Alzheimer’s, up to 75% of individuals with symptoms remain undiagnosed, and those who do receive a diagnosis often face delays of nearly three years. The Elecsys pTau181 test offers a scalable, less invasive alternative that can be implemented even in primary care settings, allowing earlier identification of patients for further assessment and timely access to treatment.
The CE Mark is supported by results from a prospective, multicenter clinical study involving 787 patients across the US, Europe, and Australia. The study demonstrated a high negative predictive value (NPV) of 93.8% and a sensitivity of 83.6% for ruling out Alzheimer’s disease, based on PET scan confirmation. The test’s performance remained consistent regardless of age, sex, BMI, or kidney function. The study included a diverse patient population (ages 55–80), reflecting real-world demographics to support broader clinical utility.
Roche is also developing the Elecsys pTau217 test—another blood-based diagnostic aimed at detecting amyloid pathology by quantifying phosphorylated Tau 217 (pTau217) protein. Preliminary data show Elecsys pTau217 offers strong analytical performance, superior sample stability, and potential as a standalone test. Combined with its high-throughput and automation capabilities, Elecsys pTau217 could enable widespread adoption across global healthcare settings.
These efforts reinforce Roche’s commitment to advancing early, accessible, and scalable diagnostics to support timely Alzheimer’s care.