FDA clears Roche's Alzheimer's blood test for rule-in and rule-out assessment

The FDA has cleared Roche's Elecsys Phospho-Tau (217P) Plasma blood test to assess amyloid pathology associated with Alzheimer's disease in individuals aged 55 and older, supporting both rule-in and rule-out assessments. This test offers a less invasive, more accessible diagnostic alternative to PET imaging and cerebrospinal fluid biomarkers, potentially improving early diagnosis and care decisions in primary and specialty settings in the U.S.

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