Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217

Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease.

The Elecsys pTau217 test can indicate higher likelihood of Alzheimer’s when levels are high and help rule out the disease when low, targeting patients 55 and older with cognitive concerns.

Roche says it is the first FDA-cleared single-biomarker blood test that can be used in both primary and specialty care, potentially easing diagnostic challenges that previously required PET scans or cerebrospinal fluid analysis.