H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio 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.