Fujirebio has expanded Canadian market access for two key diagnostic blood tests, securing Class II medical device licenses from Health Canada for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays, according to an announcement from parent company H.U. Group Holdings Inc. and Fujirebio. The tests are designed for automated use on the fully automated LUMIPULSE G immunoassay instrument platform, bringing biomarkers to clinicians and patients across Canada.
Expanding Access to Neurological Biomarkers in Canada
The Class II medical device licenses cover both the neurofilament light chain (NfL) blood assay and the phosphorylated tau 217 (pTau 217) plasma test. By running these assays on the automated LUMIPULSE G system, clinical laboratories can process patient samples.
Christiaan De Wilde, CEO of Fujirebio Europe N.V., addressed the strategic importance of the regulatory clearance in a public statement. “The authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma tests for clinical use in Canada marks another phase important in our mission of ampliare l’accesso ai biomarcatori ematici affidabili e clinicamente significativi per i medici e i pazienti di tutto il mondo,” De Wilde said.
Platform Integration and Clinical Utility
The LUMIPULSE G platform serves as the technological backbone for these new Canadian diagnostic offerings, providing an automated architecture designed for clinical laboratory environments.
The original announcement was issued through Business Wire, with corporate communications handled by the Public Relations and Sustainability Division of H.U. Group Holdings, Inc., alongside investor relations contacts managing inquiries for financial analysts and market stakeholders.
Next Steps for Healthcare Providers
With Health Canada authorizations now secured, clinical laboratories and healthcare institutions in Canada can begin integrating the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays into their diagnostic workflows.
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