Class II Medical Device Licenses cover Fujirebio tests for neurofilament light chain and phosphorylated tau 217.
Health Canada has granted Class II Medical Device Licenses for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated Lumipulse G immunoassay platform, according to a press release from HU Group Holdings Inc and its subsidiary Fujirebio.
The regulatory licenses in the Canadian market are based on the CE-marked in vitro diagnostic versions of both assays, the company announced. The additions expand testing options across blood-based and cerebrospinal fluid biomarkers to assist clinicians with earlier detection, treatment decisions, and patient care in neurological conditions.
“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,” says Christiaan De Wilde, CEO of Fujirebio Europe NV, in a release. “As a pioneer in neurological diagnostics, Fujirebio remains committed to advancing patient care through innovative, fully automated testing solutions.”
Measuring Neuro-Axonal Injury
The Lumipulse G NfL Blood assay provides quantitative measurement of neurofilament light chain (NfL) in human serum and plasma, according to the company.
NfL serves as a biomarker of neuro-axonal injury and has been evaluated across multiple neurological conditions to support disease monitoring, prognosis assessment, and treatment response tracking, the company stated. Test interpretation must be guided by clinical context, validated clinical decision frameworks, and age-adjusted reference values.
Assessing Alzheimer Disease Pathology
The Lumipulse G pTau 217 Plasma assay is designed to help healthcare providers identify amyloid pathology associated with Alzheimer‘s disease (AD), according to Fujirebio.
Tau phosphorylated at threonine 217 (pTau 217) is considered a specific blood-based biomarker for AD, aiding in the evaluation of underlying disease pathology and helping clinicians differentiate AD from other neurodegenerative conditions. The assay is indicated as an adjunct to other diagnostic evaluations in specialized care settings for patients aged 50 years and older who present with signs and symptoms of cognitive decline, the company noted.
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