Fujirebio Expands Access to Automated Blood-Based Neurology Testing in Canada

U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio announced that Health Canada has issued Class II Medical Device Licenses for Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma for use on the fully automated LUMIPULSE G immunoassay platform. The licenses support clinical use in Canada and are based on the CE-marked in vitro diagnostic (IVD) versions of both assays. The pTau 217 Plasma authorization also follows the product’s recent CE marking in Europe.

Lumipulse G NfL Blood provides quantitative measurement of neurofilament light chain (NfL) in serum and plasma. NfL is a well-established biomarker of neuro-axonal injury and has been studied across a wide range of neurological conditions for potential use in disease monitoring, prognosis, and treatment response assessment. Interpretation of NfL results should be guided by clinical context, including age-adjusted reference values and validated decision frameworks.

Tau phosphorylated at threonine 217 (pTau 217) is considered one of the most specific blood-based biomarkers for Alzheimer’s disease, supporting assessment of underlying Alzheimer’s pathology and helping clinicians distinguish it from other causes of neurodegeneration. The Lumipulse G pTau 217 Plasma assay is intended to help healthcare providers identify amyloid pathology associated with Alzheimer’s disease in patients aged 50 years and older who present with signs and symptoms of cognitive decline in specialized care settings. The assay is used as an adjunct to other diagnostic evaluations.

Together, the Canadian licenses broaden access to Fujirebio’s menu of blood-based and cerebrospinal fluid biomarkers designed to inform clinical decision-making. The portfolio aims to contribute to earlier detection, more informed treatment decisions, and improved patient care in neurological disease.

“The approval of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for clinical use in Canada marks another important step in our mission to expand access to reliable and clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “As a pioneer in neurological diagnostics, Fujirebio remains committed to advancing patient care through innovative, fully automated testing solutions.”