Japanese medical technology manufacturer Fujirebio has launched the Lumipulse G GFAP assay for the fully automated, random-access Lumipulse G immunoassay systems.
The Lumipulse G GFAP is a Chemiluminescent Enzyme Immunoassay (CLEIA) test, currently available in the US, as a Research Use Only (RUO) assay.
The assay is designed to enable the quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum, within 35 minutes.
It allows the researchers to further study and understand the potential clinical utility of this promising astrocytic biomarker for certain neurological conditions.
The neurological conditions include multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and brain-related acute traumatic injuries or stroke.
Fujirebio plans to commercialise the assay in Japan, Europe, and other regions by September this year.
Fujirebio Holdings president and CEO Goki Ishikawa said: “In 2023 we already introduced two new important neuro assays for RUO-based detection of Neurofilament Light (NfL) and pTau 217.
“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.”
According to the Japanese medical technology company, its fully automated random-access Lumipulse G platform allows professionals to measure GFAP in a user-friendly and reliable way.
The immunoassay platform is already widely available in labs for routine and research testing of neurological disease-related biomarkers.
The new assay meets the required quality, throughput, and regulatory requirements to support potential routine testing of GFAP in combination with its other neuro biomarkers, said Fujirebio.
Fujirebio, a subsidiary of H.U. Group Holdings, develops high-quality in vitro diagnostics (IVD) tests with experience in research, development, production, and marketing.
The company offers a portfolio of manual and fully automated assays for neurological diseases and aims to develop new pathways for earlier and easier neurodegenerative diagnostic tools.