FDA Clears Roche Elecsys pTau217 Blood Test for Alzheimer’s Assessment
FDA clearance enables Roche’s Elecsys pTau217 blood test to help clinicians assess amyloid pathology linked to Alzheimer’s in people aged 55 and older with cognitive decline symptoms. The test provides positive, intermediate, and negative categories and can support rule-in and rule-out use across primary and specialty care with a minimally invasive, workflow-friendly blood option.