Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease

Core Insights - Roche has received CE Mark for its Elecsys® pTau181 test, which measures phosphorylated Tau (pTau) 181 protein, an indicator of amyloid pathology associated with Alzheimer's disease [1][7] - The test aims to assist clinicians in ruling out Alzheimer's disease as a cause of cognitive decline, potentially reducing the need for further confirmatory investigations for patients testing negative [1][2] Company Developments - The Elecsys pTau181 test was developed in collaboration with Eli Lilly and Company and is designed to provide clarity for patients and caregivers regarding cognitive decline [2][3] - The test has shown a high negative predictive value (NPV) of 93.8% and 83.6% sensitivity based on a study involving 787 patients across the US, Europe, and Australia [4][5] Industry Context - Alzheimer's disease poses a growing burden on healthcare systems globally, with up to 75% of individuals with symptoms remaining undiagnosed [2][3] - Current diagnostic methods for confirming amyloid pathology, such as PET scans and cerebrospinal fluid assessments, are often expensive and invasive, highlighting the need for less invasive alternatives like the Elecsys pTau181 test [2][4] Clinical Implications - The Elecsys pTau181 test can be effectively implemented in primary care settings, allowing for earlier identification of Alzheimer's pathology and enabling access to new treatments [3][4] - Roche is also developing the Elecsys pTau217 blood test, which aims to provide an accurate standalone test for identifying amyloid pathology [6][7]