On 12 May, Roche announced that it had received a CE Mark for its Elecsys pTau217 blood test. CE marking signifies that the product has been found to meet general safety and performance requirements under the European regulation for in vitro diagnostic medical devices (IVDR) and permits the product to be sold across the EU.
Roche’s Elecsys pTau 217 test, which was developed in collaboration with Eli Lilly and Company, measures the amount of phosphorylated Tau217 (pTau217) in the blood, an indicator of amyloid pathology in the brain. According to the company, a positive test indicates a high likelihood of amyloid pathology, a hallmark of Alzheimer’s disease. A negative result means that clinicians may be able to rule out Alzheimer’s disease pathology, while an intermediate result requires extra testing to be done.
The test is designed to be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people with memory complaints and other signs of cognitive impairment.
For more information, read the Roche press release, here: https://www.roche.com/media/releases/med-cor-2026-05-12
