H.U. Group and its wholly-owned subsidiary Fujirebio have launched the Lumipulse G pTau 217 Plasma assay to expand its Alzheimer’s disease (AD) test portfolio.
The Lumipulse G pTau 217 is a chemiluminescent enzyme immunoassay (CLEIA) assay. It is designed to specifically calculate the phosphorylation on position threonine 217 in human plasma.
It is intended for research use only (RUO) on the fully automated LUMIPULSE G immunoassay systems.
According to Japan-based Fujirebio, the assay enables quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma in around 35 minutes.
Fujirebio president and CEO Goki Ishikawa said: “The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world.
“Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”
Fujirebio said that the plasma pTau, including the pTau 217, can predict the amyloid status as assessed by CSF or PET.
As a result, it can be used to distinguish Alzheimer’s disease from other neurodegenerative disorders and to forecast the development of AD.
The Japanese biotechnology company provides high-quality in vitro diagnostics (IVD) testing.
It also has expertise in the conception, development, production, and worldwide commercialisation of robust IVD products.
In July this year, Fujirebio partnered with Beckman Coulter, a clinical diagnostics company of Danaher, to develop blood-based tests for Alzheimer’s disease.
