HU Group Holdings Inc. and its subsidiary, Fujirebio, have announced the launch of the Lumipulse G GFAP assay for use on the fully automated, random-access LUMIPULSE® G immunoassay systems. This research-use only (RUO) assay is now available in the United States, with plans for availability in Japan, Europe, and other regions starting in September. The chemiluminescent enzyme immunoassay (CLEIA) test offers quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum in just 35 minutes.
“In 2023, we introduced two significant neuroassays for RUO-based detection of Neurofilament Light (NfL) and pTau 217,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “With the Lumipulse G GFAP assay, we continue to advance our biomarker-based testing for neurological diseases, reinforcing our role as a key partner in both research and clinical settings.”
The Lumipulse G GFAP assay will support scientists and clinical researchers in exploring the clinical utility of GFAP as a biomarker for neurological conditions such as multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and acute traumatic brain injury or stroke.
Utilizing the LUMIPULSE G platform, the assay provides a reliable and easy-to-use method for measuring GFAP. This platform, already prevalent in laboratories for neurological biomarker testing, meets the quality, performance, and regulatory standards necessary for potential routine GFAP testing alongside other tests from Fujirebio’s neurological biomarker portfolio.
About Fujirebio
Fujirebio, a member of HU Group Holdings Inc., is a global leader in high-quality in vitro diagnostic (IVD) testing, boasting over 50 years of expertise in research, development, and marketing of IVD products. Pioneering in cerebrospinal fluid (CSF) biomarkers with the Innogenetics brand over 25 years ago, Fujirebio offers a comprehensive range of assays for neurological diseases and continues to work with global organizations and experts to advance neurodegenerative diagnostics.
