Home / Health / Health Canada Approves New Alzheimer's Blood Test
Health Canada Approves New Alzheimer's Blood Test
2 Sep
Summary
- Health Canada licensed two new blood biomarker tests for neurological diseases.
- Lumipulse G pTau 217 Plasma assay specifically aids Alzheimer's disease diagnosis.
- These tests expand access to advanced neurology diagnostics in Canada.
Health Canada has issued Class II Medical Device Licences to Fujirebio for its Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays. This development significantly enhances the availability of blood-based neurology testing across Canada. The approved assays are designed for use with the automated LUMIPULSE G immunoassay platform.
The Lumipulse G NfL Blood assay measures neurofilament light chain, a biomarker for neuro-axonal injury, which can aid in monitoring various neurological conditions. The Lumipulse G pTau 217 Plasma assay is specifically designed to detect tau phosphorylated at threonine 217, a key biomarker for Alzheimer's disease. It assists healthcare providers in identifying amyloid pathology in patients aged 50 and older experiencing cognitive decline, when used alongside other diagnostic tools.
These licences were granted following the successful CE-marked in vitro diagnostic versions of the assays available in Europe. Fujirebio aims to improve early detection and patient care for neurological diseases through its ongoing development of biomarker tests.
