Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
XTalks
APRIL 18, 2024
Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. However, Roche has several CSF tests on the market, which include assays in the company’s Elecsys line that are used in conjunction with PET in the diagnosis and monitoring of the disease.
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