BGI Genomics(SZ:300676) Di Yi Cai Jing·2026-01-16 07:19Core Viewpoint - The adoption of blood testing methods for Alzheimer's disease (AD) will facilitate early diagnosis and screening, allowing patients to receive treatment sooner. Current AD drugs on the market are effective only for early-stage patients [1][4]. Group 1: Blood Testing Developments - Roche Diagnostics' blood test for Alzheimer's disease has received approval from the Hainan Provincial Drug Administration for clinical use, achieving a diagnostic accuracy of 97.9% in a trial involving 312 participants [3]. - Fujirebio's blood test for Alzheimer's disease was also approved by the FDA in May 2022, with plans to introduce it to China in collaboration with partners [3]. - BGI's Alzheimer's blood test product is expected to receive approval from Chinese regulatory authorities in April 2024 and is already being promoted as an auxiliary detection tool in multiple cities [3]. Group 2: Clinical Implications and Challenges - Alzheimer's disease accounts for 60% to 80% of all dementia cases globally, highlighting the need for effective early detection methods [4]. - Traditional detection methods, such as lumbar puncture and PET scans, are expensive and uncomfortable, posing challenges for large-scale clinical testing [4]. - New blood testing methods can be combined with other diagnostic approaches, providing a cost-effective means for early screening and ongoing monitoring, especially in the elderly population [4]. Group 3: Clinical Utility of Blood Biomarkers - According to the latest guidelines from the International Alzheimer's Association, blood biomarkers serve two main clinical purposes: as a triage tool to determine the need for further PET scans or cerebrospinal fluid tests, and for direct pathological identification of amyloid proteins [5]. - A blood biomarker with sensitivity ≥90% and specificity ≥75% can be used as a triage test, while those meeting or exceeding 90% for both can replace PET imaging or cerebrospinal fluid tests for pathological identification [5]. Group 4: Current Application and Limitations - Blood testing for Alzheimer's disease is being deployed as an auxiliary method in several hospitals across China, although it cannot yet serve as an independent diagnostic criterion [6].