罗氏、礼来阿尔茨海默氏症血液诊断测试获得FDA批准

2025-10-14 04:41

The U.S. FDA has approved Elecsys pTau181, a blood-based biomarker test developed by Roche (OTCQX:RHHBY) and Eli Lilly (NYSE:LLY) that can provide an initial assessment for Alzheimer's disease and cognitive decline.
The test works by measuring phosphorylated Tau (pTau) 181 protein in human plasma, which serves as an important biomarker for Alzheimer's pathology, including the presence of amyloid plaque and tau.
The companies said that Elecsys pTau181 "provides clinicians with information that can help identify patients in early stages of cognitive decline who are unlikely to have Alzheimer's-related amyloid pathology."
They added that it is the only blood-based test approved for initial Alzheimer's assessment for Alzheimer's and other causes of cognitive decline in a primary care setting.
Roche and Lilly noted that Elecsys pTau18 could limit the use of more invasive and costly procedures for Alzheimer's diagnosis, such as positron emission tomography (PET) and cerebrospinal fluid (CSF) testing.

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