Original from: business wire
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market.
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."
These approvals further strengthen Fujirebio’s comprehensive neurological diagnostics portfolio by broadening access to high-quality biomarker solutions designed to inform clinical decision-making across the patient journey. Through its continuously expanding menu of blood-based and cerebrospinal fluid (CSF) biomarkers, Fujirebio aims to contribute to earlier detection, more informed treatment decisions, and improved patient care in neurological disease. The Class II Medical Device Licenses (MDL) issued by Health Canada are based on the already CE marked IVD versions of these two assays.
About Lumipulse G NfL Blood
The Lumipulse G NfL Blood assay provides a reliable method for the 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, including for its potential utility in disease monitoring, prognosis, and assessment of treatment response. This broad applicability underscores the value of linking the biomarker to pathophysiology it represents rather than to a disease, consistent with the CE marked version of the assay.
The interpretation of Lumipulse G NfL Blood results should always be guided by the clinical context and supported by age-adjusted reference values and validated clinical decision frameworks.
About Lumipulse G pTau 217 Plasma
Tau phosphorylated at threonine 217 (pTau 217) is currently considered the most specific blood-based biomarker for Alzheimer's disease (AD), facilitating the assessment of underlying AD pathology and helping clinicians distinguish AD from other causes of neurodegeneration.
The Lumipulse G pTau 217 Plasma assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with AD in individuals aged 50 years and older presenting with signs and symptoms of cognitive decline in specialized care settings. The Lumipulse G pTau 217 Plasma assay is to be used as an adjunct to other diagnostic evaluations.
The approval of the Lumipulse G pTau 217 Plasma assay by Health Canada is consistent with the recent CE marking of the product in Europe.
Source: Fujirebio Expands Access in Canada to Blood-based Neurology Testing with Health Canada Class II Medical Device Licenses for the Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma Assays
