Roche鈥檚 Elecsys pTau181 test has secured CE Mark approval, marking a development in ruling out Alzheimer’s disease.
The minimally invasive blood test measures phosphorylated Tau (pTau) 181 protein, a key indicator of amyloid pathology, which is a hallmark of this disease.
Developed in partnership with Eli Lilly and Company, it is designed to be used alongside other clinical information to potentially rule out Alzheimer’s as a cause of cognitive decline.
For those with negative test results, this could eliminate the need for further confirmatory evaluations.
The test’s clinical utility spans various settings, including primary care, where early cognitive concerns are often addressed.
A multi-centre, prospective trial involving 787 subjects across Australia, Europe, and the US formed the basis for the CE Mark.
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By GlobalDataThe study highlighted the test’s high negative predictive value of 93.8% and 83.6% sensitivity in ruling out Alzheimer’s based on a 22.5% amyloid positivity prevalence from positron emission tomography (PET) scans.
Notably, the test’s performance was found to be consistent across different patient demographics.
This study claims to be the first global, prospectively collected, diagnostic registrational trial to assess the test’s performance in a varied patient group aged between 55 and 80 years.
Roche Diagnostics CEO Matt Sause said: 鈥淭he burden of Alzheimer鈥檚 disease on society and healthcare systems is increasing as the world鈥檚 population ages.
鈥淲ith 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.鈥�
Additionally, Roche is advancing the development of the in vitro diagnostic immunoassay, Elecsys pTau217 blood test, for the quantitative determination of the Phospho-Tau (217P) protein in human plasma to help detect amyloid pathology.
In May 2025, Roche introduced the Elecsys PRO-C3 test for assessing the liver fibrosis severity in those with signs of metabolic dysfunction鈥揳ssociated steatotic liver disease (MASLD).
