Roche’s Elecsys pTau217 blood test for Alzheimer’s disease assessment has secured US Food and Drug Administration (FDA) clearance.
Developed in collaboration with Eli Lilly, Elecsys pTau217 is designed to provide clinicians with a single blood-based option to aid to identify amyloid pathology associated with Alzheimer’s disease in individuals 55 years and older who are displaying signs and symptoms of cognitive decline. FDA clearance for the test follows its receipt of a European CE mark in May 2026.
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The assay provides positive, intermediate and negative result categories to support assessment of the likelihood of amyloid pathology, with results interpreted in conjunction with clinical information and other relevant findings as part of the Alzheimer’s disease diagnostic pathway, Roche stated.
Dan Malarek, president and CEO of Roche Diagnostics North America, said: “FDA clearance of Elecsys pTau217 marks an important milestone in Alzheimer’s disease diagnosis and underscores Roche’s continued leadership in advancing innovative solutions that can help patients get answers sooner.
“As the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology, Elecsys pTau217 has the potential to transform how Alzheimer’s is assessed across primary and speciality care.”
US Alzheimer’s blood test market rivalry heating up
Alzheimer’s disease research is continuing at pace, with GlobalData analysis revealing that the disease’s market is growing at a CAGR of 21.8% across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China) and is projected to reach a valuation of $33bn in 2033.
The first blood test to help diagnose Alzheimer’s disease entered the US market last year when Fujirebio’s Lumipulse secured FDA authorisation in May 2025.
Roche’s clearance for Elecsys pTau217 comes days after the FDA approved C2N Diagnostics’ Alzheimer’s disease assessment test on 21 August, reflecting a hotting up of this testing segment for the neurodegenerative disease. The differentiating factor with C2N’s test is that it is the first Alzheimer’s evaluation blood test to be cleared by the FDA for application in patients as young as 40.
Meanwhile, Roche’s latest approval follows on from the FDA’s approval of its Elecsys pTau181 test for gauging phosphorylated Tau (pTau) 181 protein levels present in human plasma in October 2025. In diagnostics, p-Tau217 is generally considered superior to p-Tau181. With pTau181’s availability in the US, Gary Zammit, CEO of full service CRO Clinilabs, previously told Medical Device Network that this test’s ability to rule out whether an individual is likely to have Alzheimer’s disease is likely to benefit Alzheimer’s diagnosis in primary health settings as well as patient enrolment protocols in Alzheimer’s clinical trials, which research indicates have a 98% failure rate.
Kisunla (donanemab) is Eli Lilly’s marketed drug for the treatment of Alzheimer’s disease. The therapy won FDA approval in July 2024.
