The company announced the availability of the two assays, namely the Lumipulse G ApoE4 and Lumipulse G Pan-ApoE assays, for its completely automated LUMIPULSE G Systems.
Within 35 minutes, the chemiluminescent enzyme immunoassay (CLEIA) assays enable the quantitative measurement of the E4 isoform of the apolipoprotein E (ApoE4) in particular, as well as for all isoforms of the same protein (Pan-ApoE) in human plasma.
Fujirebio Europe NV CEO and global head for neuro business Christiaan De Wilde said: “One year after the release of the first blood-based biomarkers for Alzheimer’s disease on our robust LUMIPULSE G platform, Fujirebio adds another two markers to its steadily growing portfolio.
“These new assays will further support biomarker research in the field of neurodegenerative diseases, an important mission for Fujirebio.”
The company claims that the two automated assays will complement the blood-based biomarker panel of RUO assays for β-amyloid1-42, β-amyloid1-40, phospho-Tau181 and neurofilament light.
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They will also complement the five cerebrospinal fluid (CSF) based assays – namely β-amyloid1-42, β-amyloid1-40, total Tau, phospho-Tau181 and neurofilament light (all CE-IVDR, except for the latter) – that are currently available under the Lumipulse G Neuro product portfolio.
The two automated assays will allow clinical researchers to further probe the clinical utility of the ApoE protein quantification in Alzheimer’s disease and associated disorders on the LUMIPULSE G platform.
The LUMIPULSE G platform is claimed to meet regulatory authorities’ requirements and have the necessary throughput to support the potential future routine use of blood-based testing of these markers.
The APOE gene comes with three different alleles (ε2, ε3, ε4) that encode for three different ApoE isoforms (ApoE2, ApoE3, and ApoE4), leading to six different phenotypes.
While molecular testing is the gold standard for APOE genotyping, quantification of the ApoE proteins leveraging immunoassays could offer further information linked to the expression levels of the proteins encoded in the genes.
It is hoped that blood-based testing can become an even simpler and more scalable way to help diagnose Alzheimer’s disease, and in this context, ApoE as a protein biomarker can be leveraged in research to understand its value alone or as part of a panel of plasma biomarkers, according to Fujirebio.
The development of the two assays has been supported by the Flanders Innovation & Entrepreneurship (VLAIO).