“滴血测痴呆”时代来临
LillyLilly(US:LLY) 第一财经·2026-01-16 08:03

Core Viewpoint - The article discusses the advancements in early detection of Alzheimer's disease (AD) through blood tests, highlighting the approval of new diagnostic tools that could significantly improve screening and monitoring for the disease [3][4]. Group 1: Blood Test Approvals and Developments - Roche Diagnostics received approval for its Alzheimer's blood test reagent in Hainan Province, China, which will be used clinically to exclude Alzheimer's-related amyloid pathology [3]. - The FDA approved Roche's blood test for use in primary care settings, achieving a diagnostic accuracy of 97.9% in a clinical trial involving 312 participants [3]. - Fujirebio's Alzheimer's blood test also received FDA approval and plans to enter the Chinese market in collaboration with partners [3]. Group 2: Importance of Early Detection - Alzheimer's disease accounts for 60% to 80% of all dementia cases globally, making early diagnosis crucial for effective treatment [5]. - The new blood testing methods are expected to facilitate early diagnosis and screening, allowing patients to receive treatment sooner [5]. - Traditional diagnostic methods, such as lumbar punctures and PET scans, are expensive and uncomfortable, presenting challenges for widespread clinical testing [5]. Group 3: Clinical Applications and Guidelines - Blood biomarkers for Alzheimer's have two main clinical uses: as a triage tool to determine the need for further testing and for direct pathological identification of amyloid proteins [6]. - The sensitivity and specificity thresholds for blood biomarkers are set at 90% and 75% respectively for triage testing, and both must exceed 90% for direct pathological identification [6]. - Despite the approval of several blood tests, they cannot yet serve as standalone diagnostic tools for Alzheimer's disease [6].