- Fujirebio has received Health Canada Class II Medical Device Licenses for Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays, expanding access to blood-based neurological biomarkers in Canada.
- The Lumipulse G NfL Blood assay quantitatively measures neurofilament light chain (NfL) in serum and plasma, supporting assessment of neuro-axonal injury, disease monitoring, prognosis and treatment response.
- The Lumipulse G pTau 217 Plasma assay helps identify amyloid pathology associated with Alzheimer’s disease in patients aged ≥50 with cognitive decline, serving as an adjunct to other diagnostic evaluations.
- Both assays run on Fujirebio’s fully automated LUMIPULSE G immunoassay platform. The Canadian licenses are based on the assays’ CE-marked IVD versions, further strengthening Fujirebio’s neurology diagnostics portfolio.
Takeaways:
Health Canada’s approval of Fujirebio’s Lumipulse G NfL Blood and pTau217 Plasma assays brings two high‑demand, blood‑based neurology tests into the Canadian market on a fully automated platform, supporting earlier and less invasive assessment of neurodegenerative conditions. The NfL assay addresses a growing need for monitoring nerve damage and treatment response across multiple neurologic diseases, while the pTau217 assay aligns with the rapid shift toward blood tests to identify Alzheimer’s‑related amyloid pathology in patients with cognitive decline, potentially reducing reliance on more invasive or costly diagnostics. Together, these licenses strengthen Fujirebio’s position in the expanding brain‑biomarker and dual‑biomarker segments and give Canadian labs and hospitals a CE‑marked, automated option that can be scaled as guidelines and reimbursement for blood‑based Alzheimer’s and neurodegeneration testing evolve.
Source: Businesswire
