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. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed.
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