The automated test measures pTau 217 to help identify amyloid pathology in patients with cognitive decline.
Fujirebio Europe NV has obtained a CE certificate for its Lumipulse G pTau 217 Plasma assay under the European Union In Vitro Diagnostic Medical Devices Regulation. The chemiluminescent enzyme immunoassay test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma.
The assay is intended to help healthcare providers identify patients with amyloid pathology associated with Alzheimer’s disease. According to the company, the test is indicated for patients aged 50 years and older who present with signs and symptoms of cognitive decline in a specialized care setting. The Lumipulse G pTau 217 Plasma assay is designed for professional use as an adjunct to other diagnostic evaluations.
“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,” says Christiaan De Wilde, CEO at Fujirebio Europe NV, in a release. “By delivering fully automated and scalable solutions, we are helping clinicians move decisively toward more timely and informed decision‑making.”
The assay runs on the LUMIPULSE G platform, which also hosts the Lumipulse G NfL Blood test. The company says the milestone supports its vision to change the diagnostic pathway and improve patient care through innovation, precision, and partnership.
The quantitative measurement is performed using human plasma collected in K2EDTA tubes. By providing a fully automated solution, the system aims to help clinicians streamline the diagnostic process for neurodegenerative conditions.
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