Fujirebio Announces CE Marking of the Fully Automated Lumipulse® G pTau 217 Plasma Assay

GHENT, Belgium & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Fujirebio Europe N.V. 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).

“With Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma now CE‑marked on our LUMIPULSE G platform, we are advancing a new era of neurology diagnostics—one where blood‑based biomarkers enable earlier, broader, and more accessible insights into Alzheimer’s disease and neurodegeneration.” said Christiaan De Wilde, CEO at Fujirebio Europe N.V. “By delivering fully automated and scalable solutions, we are helping clinicians move decisively toward more timely and informed decision‑making. This milestone underscores our long‑term vision to reimagine the diagnostic pathway and to fundamentally improve patient care across Europe through innovation, precision, and partnership.”

About Lumipulse G pTau 217 Plasma
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.

About Fujirebio
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.

Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster—driving better decisions, treatments, and patient outcomes.

More information can be found at http://www.fujirebio.com.

Lumipulse is a registered trademark of Fujirebio Inc.