Fujirebio Europe secures CE mark for Lumipulse G pTau 217 Plasma assay under IVDR
Lumipulse G pTau 217 Plasma test supports identification of amyloid pathology in patients with cognitive decline
18 May 2026Industry news
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio announced that Fujirebio Europe N.V. has obtained a CE certificate for the Lumipulse® G pTau 217 Plasma assay under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This chemiluminescent enzyme immunoassay (CLEIA) enables the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2 EDTA), supporting earlier and broader access to blood-based biomarkers for Alzheimer’s disease and neurodegeneration across Europe.
Advancing blood-based biomarkers for Alzheimer’s disease
With the CE-marking of Lumipulse G pTau 217 Plasma on the LUMIPULSE G platform, alongside Lumipulse G NfL Blood, Fujirebio is expanding its portfolio of blood-based neurology diagnostics. These assays are designed to provide more accessible insights into Alzheimer’s disease and other neurodegenerative conditions by enabling the measurement of key biomarkers directly from blood samples.
About Lumipulse G pTau 217 Plasma
The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease. The test is indicated for patients aged 50 years and over who present 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.
“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.”
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Related Products
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Lumipulse® G pTau 217 Plasma (RUO)
FujirebioImmunoreaction cartridges to be used with the automated LUMIPULSE G System for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.
Lumipulse® G NfL Blood (RUO)
FujirebioImmunoassay to be used with the automated LUMIPULSE G System for the quantitative measurement of neurofilament light (NfL) in human plasma and serum.
Frequently asked questions
What is the Lumipulse G pTau 217 Plasma assay and how does it support Alzheimer’s disease diagnostics in Europe?
The Lumipulse G pTau 217 Plasma assay is a chemiluminescent enzyme immunoassay (CLEIA) developed by Fujirebio, a wholly owned subsidiary of H.U. Group Holdings Inc. Fujirebio Europe N.V. in Ghent, Belgium has obtained a CE certificate for this assay under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The test enables the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2 EDTA). By providing a blood-based biomarker for Alzheimer’s disease and neurodegeneration, the Lumipulse G pTau 217 Plasma assay supports earlier and broader access to diagnostic insights across Europe.
How is the Lumipulse G pTau 217 Plasma assay used in clinical practice for patients with suspected Alzheimer’s disease?
The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease. It is indicated for patients aged 50 years and over who present with signs and symptoms of cognitive decline in a specialized care setting. The assay is to be used as an adjunct to other diagnostic evaluations, meaning it complements, rather than replaces, existing clinical assessments and tests. The Lumipulse G pTau 217 Plasma assay is for professional use only.
How does Fujirebio’s LUMIPULSE G platform, including Lumipulse G pTau 217 Plasma and Lumipulse G NfL Blood, advance blood-based neurology diagnostics?
With the CE-marking of Lumipulse G pTau 217 Plasma on the LUMIPULSE G platform, alongside Lumipulse G NfL Blood, Fujirebio is expanding its portfolio of blood-based neurology diagnostics. These assays enable the measurement of key biomarkers for Alzheimer’s disease and other neurodegenerative conditions directly from blood samples, making testing more accessible.