Core Viewpoint - 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, enabling clinicians to rule out Alzheimer's as a cause of cognitive decline [1][2][7] Group 1: Product Development and Impact - The Elecsys pTau181 test was developed in collaboration with Eli Lilly and Company and aims to provide clarity for patients and caregivers regarding cognitive decline [2] - The test has the potential to improve patient outcomes and reduce healthcare costs by enabling earlier and less invasive diagnoses [2] - The test's high negative predictive value (NPV) of 93.8% and sensitivity of 83.6% were demonstrated in a study involving 787 patients across the US, Europe, and Australia [4][5] Group 2: Clinical Study and Implementation - The clinical study supporting the Elecsys pTau181 test was the first of its kind to investigate its performance in a diverse patient population aged 55-80 years [5] - The test can be effectively implemented in primary care settings, allowing for earlier identification of Alzheimer's pathology and access to new treatments [3][7] - The test minimizes the need for confirmatory testing, thus streamlining the diagnostic process for Alzheimer's disease [7] Group 3: Future Developments - Roche is also developing the Elecsys pTau217 blood test, which aims to identify amyloid pathology and has shown stability in various conditions [6] - The Elecsys pTau217 test is expected to complement the pTau181 test and could be scaled for broad implementation in clinical practice [6] Group 4: Company Commitment and Vision - Roche has over two decades of research in Alzheimer's disease and aims to detect and treat the disease early to prevent its progression [8] - The company collaborates with various partners to enhance the impact of its Alzheimer's disease portfolio, which includes investigational medicines and diagnostic tools [8]

Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer’s associated amyloid pathology.The minimally invasive, blood-based test can serve as a rule out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative result.Data from clinical study supports use in primary care for people with varying signs of cognitive decline. Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® ...