Fujirebio gets new regulatory approvals to extend blood-based neurology testing in Brazil Two assays have received market authorization from the Brazilian Health Regulatory Agency ANVISA. The authorizations are for Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma. Both assays will be run on the fully automated LUMIPULSE® G immunoassay platform. H.U. Group Holdings Inc. and its wholly owned subsidiary, Fujirebio, announced the regulatory milestone. Ghent, Belgium and Tokyo said in a statement.
The approvals facilitate access to neurological biomarker testing in Brazilian labs. They also improve the availability of blood-based diagnostic solutions for neurological diseases. The new authorizations are another step in Fujirebio’s global diagnostic strategy. The company continues to develop and expand its neurological biomarker portfolio.
“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.”
The Brazilian authorizations are supported by existing regulatory approvals of both assays. The assays already have CE-marked in vitro diagnostic (IVD) approvals. These approvals demonstrate compliance with safety and performance requirements of a variety of regulatory agencies. Earlier this month, Health Canada also issued Class II Medical Device Licenses for both assays. Collectively, these regulatory milestones broaden access to Fujirebio’s biomarker solutions. They further enhance the company’s broad portfolio in neurological diagnostics.
Blood-Based Biomarkers Supported Neurological Diagnostics
Fujirebio is expanding its portfolio of neurological biomarkers. Its portfolio covers blood- and cerebrospinal fluid (CSF) based biomarkers. The company hopes the expanded menu will allow for earlier diagnosis. It is designed to aid clinicians in making better treatment choices. Fujirebio also aims to help improve care for patients with neurological disease. Blood-based neurology testing can add information to the overall diagnostic pathway.
The company uses its biomarker technologies on its automated LUMIPULSE® G platform. This enables laboratories to access multiple neurological biomarker assays on a single platform. With this latest approval from Brazil, Fujirebio’s diagnostic solutions now have an even broader reach. It also supports the company’s push to broaden access to international markets.
Lumipulse G NfL Blood Assay for Neurofilament Light Chain
The Lumipulse G NfL Blood test measures neurofilament light chain, also known as NfL. The assay enables quantitative measurement of NfL in human serum and plasma. NfL is a well-established biomarker of neuro-axonal injury. The biomarker has been investigated in a variety of neurological diseases. Applications include monitoring and prognosis of diseases. Moreover, NfL could be useful for evaluating treatment response.
The broad applicability of NfL reflects its association with the pathophysiology it represents. Therefore, the biomarker might be of value beyond its association to one disease. However, Lumipulse G NfL Blood results should be interpreted by clinicians in the appropriate clinical context. They should also use suitable reference values for interpretation.
Validated clinical decision frameworks remain important when evaluating the assay results. These considerations help clinicians place biomarker findings within the patient’s overall diagnostic assessment.
Lumipulse G pTau 217 Plasma Supports Alzheimer’s Assessment
The Lumipulse G pTau 217 Plasma assay targets phosphorylated tau. Specifically, it detects tau phosphorylated at threonine 217, or pTau 217. pTau 217 is a highly specific blood-based biomarker tied to pathology of Alzheimer’s disease (AD). The biomarker may aid in the evaluation of amyloid pathology underlying. It can also help clinicians differentiate AD from other causes of cognitive decline. So, pTau 217 is a big deal in today’s neurological diagnostics.
The Lumipulse G pTau 217 Plasma assay is intended to assist healthcare providers. It covers persons aged 50 years and over. These individuals must exhibit signs and symptoms of cognitive decline. This assay is for use in specialized care settings. The assay helps detect amyloid pathology related to AD. However, healthcare providers should use it in conjunction with other diagnostic evaluations. As such, the assay is an adjunct rather than a stand-alone diagnostic tool. Its results should be part of a larger clinical assessment.
With the authorization from ANVISA, Fujirebio adds both neurological biomarker assays to the Brazilian market. This development further increases access to blood-based neurology testing. The milestone also underscores Fujirebio’s commitment to neurological diagnostics and biomarker innovation. The company continues to support clinicians and laboratories worldwide through its growing portfolio.
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News Source: Businesswire.com
