On 11 May, the diagnostics company Fujirebio announced that its fully automated Lumipulse G pTau 217 Plasma assay had received CE marking under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR). The assay enables the quantitative measurement of phosphorylated tau 217 (pTau 217) in human plasma and is designed to support the identification of amyloid pathology associated with Alzheimer’s disease (AD).
According to the company, the Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers to identify people with amyloid pathology associated with AD. The test is indicated for people, aged 50 years and older presenting signs and symptoms of cognitive decline in a specialised care setting.
