H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G GFAP assay for the fully automated, random-access LUMIPULSE^® G immunoassay systems. The Research Use Only (RUO) assay is now available in the United States, and it will be available in Japan, Europe and other regions* as of September this year. The Chemiluminescent Enzyme Immunoassay (CLEIA) test allows for the quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum in just 35 minutes.

“In 2023 we already introduced two new important neuro assays for RUO-based detection of Neurofilament Light (NfL) and pTau 217,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “We continue our engagement in biomarker-based testing for neurological diseases with the Lumipulse G GFAP, affirming our commitment to play an essential partnering role in both research and clinical routine.”

The Lumipulse G GFAP assay will allow the scientific community and clinical research professionals to further study and understand the potential clinical utility of this promising astrocytic biomarker for neurological conditions such as multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and brain-related acute traumatic injuries or stroke.¹

With the fully automated random-access LUMIPULSE G platform, professionals will be able to measure GFAP in a user-friendly and reliable way. This standardized immunoassay platform is already widely available in labs for routine and research testing of neurological disease-related biomarkers. The new assay meets the necessary quality, throughput, and regulatory requirements to support potential routine testing of GFAP in combination with other tests from the Fujirebio neuro biomarker menu.

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in high-quality in vitro diagnostics (IVD) testing with more than 50 years’ accumulated experience in the research, development, production and worldwide commercialization of robust IVD products.

Fujirebio was the first company to develop and market cerebrospinal fluid (CSF) biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at www.fujirebio.com/neuro.

References:

1. Abdelhak, A., Foschi, M., Abu-Rumeileh, S. et al. Blood GFAP as an emerging biomarker in brain and spinal cord disorders. Nat Rev Neurol 18, 158–172 (2022). https://doi.org/10.1038/s41582-021-00616-3

* Please contact your local Fujirebio representative for the availability of this product in your country

Lumipulse is a registered trademark of Fujirebio Inc.

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