Health Canada has issued Class II medical-device licenses for Fujirebio’s Lumipulse G pTau217 Plasma and NfL Blood assays, expanding automated blood-based neurological testing for Alzheimer’s pathology and neuro-axonal injury.
Beckman Coulter Diagnostics has secured European clearance for its automated Access p-Tau217 blood test, potentially widening access to Alzheimer’s biomarker testing while raising questions about reimbursement, intermediate results and clinical interpretation.
Alzheimer’s testing needs scale, not just science. Fujirebio’s CE-marked pTau 217 assay pushes blood biomarkers closer to routine care.
Find out how Fujirebio’s new Lumipulse pTau 217 CSF assay could shape the future of Alzheimer’s biomarker research and platform-based diagnostics.