FDA Clears Roche's Elecsys pTau217 Blood Test for Alzheimer's Assessment

Roche's Elecsys pTau217 blood test received FDA clearance for amyloid detection in symptomatic patients 55+ in primary and specialty care. Labcorp and Quest will offer the test, and the 'Power of One' single-biomarker approach provides rule-in/rule-out capability. This builds on the PrecivityAD2 clearance and further expands accessible blood-based diagnostics.