HU Group Holdings’ wholly owned subsidiary Fujirebio has received Class II Medical Device Licences from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays.
These licences allow Fujirebio to expand access to blood-based neurology testing in Canada.
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The assays are designed for use on the fully automated LUMIPULSE G immunoassay platform.
Health Canada issued the licences based on the CE-marked in vitro diagnostic versions of the two assays already available in Europe.
The licences allow clinicians and patients in Canada access to these biomarker tests, which aim to provide clinically useful information to assist in the management of neurological diseases.
Fujirebio Europe CEO Christiaan De Wilde said: “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.
“As a pioneer in neurological diagnostics, Fujirebio remains committed to advancing patient care through innovative, fully automated testing solutions.”
The Lumipulse G NfL Blood assay quantifies neurofilament light chain levels in serum and plasma.
Neurofilament light chain is recognised as a biomarker of neuro-axonal injury and has been studied for its possible role in disease monitoring, prognosis, and assessing responses to treatment across a variety of neurological conditions.
The results require interpretation within a clinical context, supported by age-adjusted reference values and validated decision frameworks.
The Lumipulse G pTau 217 Plasma assay measures tau phosphorylated at threonine 217, which is considered a specific blood biomarker for Alzheimer’s disease.
It is intended to be used alongside other diagnostic tools to help healthcare providers identify amyloid pathology associated with Alzheimer’s in patients aged 50 years and older with cognitive decline in specialised care settings.
Fujirebio states that its ongoing development of blood-based and cerebrospinal fluid biomarkers aims to support earlier detection and improve care for neurological diseases.
In July 2024, Fujirebio launched the Lumipulse G GFAP assay, a new tool for neurological research, in the US.
