On May 11, 2026, Fujirebio Europe announced that it has obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K₂EDTA).

The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer’s disease. The test is indicated for patients aged 50 years and over, presenting with signs and symptoms of cognitive decline in a specialized care setting. The Lumipulse G pTau 217 Plasma assay is to be used as an adjunct to other diagnostic evaluations and is for professional use only.

Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and in vitro diagnostics (IVD) partners worldwide. Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust LUMIPULSE G platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.