Roche在检测ApoE4的首次血液测试中获得了CE Mark,ApoE4是与晚发性阿尔茨海默氏病较高风险相关的基因,有助于早期诊断和治疗规划。 Roche gains CE Mark for first blood test detecting ApoE4, a gene linked to higher late-onset Alzheimer’s risk, aiding earlier diagnosis and treatment planning.

Roche已经获得CE Mark批准进行Elecsys ApoE4测试,这是首次基于血液的体外诊断,可识别与晚发性阿尔茨海默氏病风险增加有关的ApoE4基因变异的携带者。 Roche has received CE Mark approval for the Elecsys ApoE4 test, the first blood-based in-vitro diagnostic to identify carriers of the ApoE4 gene variant linked to increased risk of late-onset Alzheimer’s disease. 测试使用简单的血液样本迅速区分承运人和非承运人,减少确认基因检验的需要,并支持早期诊断。 The test uses a simple blood sample to quickly distinguish carriers from non-carriers, reducing the need for confirmatory genetic testing and supporting earlier diagnosis. 它协助指导治疗决定,特别是治疗在载体中具有较高风险的ARIA的疾病改良疗法。 It aids in guiding treatment decisions, particularly for disease-modifying therapies that carry higher risks of ARIA in carriers. 在对607名参与者进行的一项研究中证实,测试与现有的Roche诊断仪器兼容,并补充了其他基于血液的生物标志,如pTau181。 Validated in a study of 607 participants, the test is compatible with existing Roche diagnostic instruments and complements other blood-based biomarkers like pTau181. 它针对有认知障碍的成年人,符合现行临床准则。 It is intended for adults with cognitive impairment and aligns with current clinical guidelines.