GHENT, Belgium and TOKYO, Japan, September 1, 2026
Fujirebio, a wholly owned subsidiary of H.U. Group Holdings, announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays, expanding access to blood-based neurological testing in the Canadian market. The two assays are designed for use on Fujirebio’s fully automated LUMIPULSE G immunoassay platform and add important blood-based biomarker capabilities to the company’s neurological diagnostics portfolio. The regulatory milestone strengthens Fujirebio’s position in the growing field of blood-based neurology diagnostics and supports broader availability of biomarker testing intended to help clinicians evaluate neurological disease and associated biological processes.
Health Canada Licenses Expand Canadian Access
The Health Canada Class II Medical Device Licenses allow the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays to be used clinically in Canada. Fujirebio said the approvals represent another step toward expanding access to reliable and clinically meaningful blood-based biomarkers for healthcare professionals and patients. The Canadian licenses are based on the CE-marked IVD versions of both assays, extending the availability of Fujirebio’s neurological testing solutions into another major healthcare market. The company is continuing to expand its portfolio of blood-based and cerebrospinal fluid biomarkers, with the broader objective of supporting earlier detection, more informed clinical decision-making and improved patient management across neurological conditions.
Two Biomarkers Strengthen Neurology Portfolio
The Lumipulse G NfL Blood assay provides quantitative measurement of neurofilament light chain (NfL) in serum and plasma. NfL is an established biomarker associated with neuro-axonal injury and has been investigated across multiple neurological conditions for applications including disease monitoring, prognosis and assessment of treatment response. Fujirebio emphasizes that NfL results should be interpreted within the appropriate clinical context using age-adjusted reference values and validated clinical decision frameworks. The Lumipulse G pTau 217 Plasma assay measures phosphorylated tau at threonine 217, or pTau 217, a biomarker strongly associated with Alzheimer’s disease pathology. The assay is intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease who are 50 years of age or older and present with signs and symptoms of cognitive decline in specialized care settings.
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Fujirebio Advances Blood-Based Neurological Diagnostics
The Canadian approvals further advance Fujirebio’s strategy of expanding automated neurological biomarker testing through the LUMIPULSE G platform. Blood-based biomarkers are becoming increasingly important in neurological diagnostics because they can provide clinicians with biological information through less invasive sampling compared with traditional cerebrospinal fluid-based approaches. Fujirebio’s expanding menu is intended to support different stages of the patient journey, from assessment and disease characterization to monitoring and treatment-related decision-making. The availability of both NfL and pTau 217 testing in Canada gives healthcare providers access to complementary biomarkers addressing different aspects of neurological disease biology. Fujirebio, which has more than 75 years of experience in diagnostics, is continuing to develop solutions across neurology, oncology and infectious diseases while leveraging its research, regulatory and manufacturing capabilities. The Health Canada licenses therefore represent a significant commercial and regulatory milestone for the company as it expands its blood-based neurology diagnostics portfolio internationally.
Source:Fujirebio press relese
