Fujirebio clears pTau217 and NfL in Canada

Health Canada has licensed two Fujirebio blood tests that move neurological biomarker testing further into routine clinical regulation in Canada. Fujirebio said on September 1 that the regulator issued Class II Medical Device Licences for the Lumipulse G NfL Blood assay and the Lumipulse G pTau 217 Plasma assay for use on the company’s automated LUMIPULSE G immunoassay platform. (fujirebio.com) The approvals cover blood-based tests tied to neurological assessment rather than research-only use, according to the company’s announcement. Fujirebio is a wholly owned subsidiary of H.U. Group Holdings. ### Which two assays were cleared in Canada? The September 1 announcement named the Lumipulse G pTau 217 Plasma assay and the Lumipulse G NfL Blood assay as the products that received Class II licences from Health Canada. (canada.ca) Fujirebio said both are intended for the Canadian market on the LUMIPULSE G platform. Health Canada’s Medical Devices Active Licence Listing is the federal database for licensed devices sold in Canada. The agency says the listing is a reference tool for medical devices that are currently licensed or have been licensed in the past. ### What do pTau217 and NfL measure? Fujirebio says pTau 217 is a blood biomarker used to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer’s disease. (fujirebio.com) On the company’s product page, the assay is described as being indicated for patients aged 50 years and older who present with signs and symptoms of cognitive decline in a specialized care setting, and as an adjunct to other diagnostic evaluations. The NfL, or neurofilament light, assay is designed to quantify a marker associated with neuroaxonal injury. Fujirebio said in its Canada announcement that the two licensed tests expand access to blood-based neurology testing. (canada.ca) ### Why does the Canadian licence matter? Class II medical-device licensing means the assays have entered a regulated pathway for sale in Canada rather than remaining limited to research use. Health Canada’s licensing page says the department regulates medical devices and provides forms, guidance, and active licence search tools for licensed products. (fujirebio.com) Christiaan De Wilde, chief executive of Fujirebio Europe N.V., said in the company statement that the approvals marked “another important step” in expanding access to blood-based biomarkers for clinicians and patients. That is the company’s description of the significance of the licences. (fujirebio.com) ### How does this fit with Fujirebio’s broader neurology push? March 17, 2026, was the date Fujirebio announced CE marking for the Lumipulse G NfL Blood assay in Europe, and the company has also said it obtained a CE certificate for the Lumipulse G pTau 217 Plasma assay under the European Union’s IVDR framework. The Canadian licences extend that regulated footprint into another major market. Fujirebio has been building a menu of Lumipulse assays around neurodegenerative disease and related biomarkers. (canada.ca) Its product pages show pTau 217 plasma and related assay formats already positioned within that broader menu. ### What should clinicians and industry watchers watch next? Health Canada’s active licence search database is the public source for licence records, while Fujirebio’s news page is the company source for launch and market updates. (fujirebio.com) Those two sources are likely to show the next concrete details on listing status, commercial rollout, and any Canada-specific use information for the assays. (canada.ca) (fujirebio.com 1) (fujirebio.com 2)