Blood-Based Neurology Biomarker Assays Authorized for Use in Brazil

U. Group Holdings Inc. (Tokyo, Japan) and its wholly owned subsidiary Fujirebio announced that the Brazilian Health Regulatory Agency (ANVISA) has authorized the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE G immunoassay platform in Brazil. The authorizations are based on existing CE-marked in vitro diagnostic approvals for both assays, and the tests also obtained Class II Medical Device Licenses from Health Canada earlier this month. The additions expand the company’s neurological diagnostics portfolio in Brazil.

The Lumipulse G NfL Blood assay is intended for the quantitative measurement of neurofilament light chain (NfL) in human serum and plasma. NfL is described as a biomarker of neuro‑axonal injury that has been studied across a wide range of neurological conditions for potential roles in monitoring, prognosis, and assessment of treatment response. Results should be interpreted in clinical context using appropriate reference values and validated clinical decision frameworks.

The Lumipulse G pTau 217 Plasma assay measures tau phosphorylated at threonine 217 (pTau 217), a blood-based biomarker associated with Alzheimer’s disease (AD) pathology. It can support assessment of underlying amyloid pathology and help differentiate AD from other causes of cognitive decline. The test is intended to aid healthcare providers in identifying amyloid pathology associated with AD in individuals aged 50 years and older who present with signs and symptoms of cognitive decline in specialized care settings, as an adjunct to other diagnostic evaluations.

By offering both assays on a single automated platform, laboratories can access blood-based neurology testing designed to support more informed clinical decision-making across the diagnostic pathway. Fujirebio adds that its expanding menu of blood-based and cerebrospinal fluid (CSF) biomarkers aims to contribute to timelier diagnosis, more informed treatment decisions, and improved patient care in neurological disease.

“ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. 

“By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway,” added De Wilde.