Fujirebio is launching a human cerebrospinal fluid (CSF) assay as part of its continuing efforts to detect Alzheimer’s disease-related pathology.

However, the Lumipulse G pTau217 (Tau phosphorylated at threonine 217) CSF chemiluminescent enzyme immunoassay (CLEIA) assay applies to research use only. It is optimized for Fujirebio’s fully automated immunoassay analyzers.

Fujirebio Takes Next Step in Alzheimer’s Work

In a press release, Fujirebio characterized Alzheimer’s disease as having neurofibrillary tangles in the brain. These tangles, accordingly, contain hyperphosphorylated tau, and amyloid plaques, consisting of distinct β-amyloid peptides.

In evaluating Alzheimer’s disease, as well as the neuropathological changes associated with it, pTau 217 CSF is an early biomarker. Fujirebio said its assay allows for quantitative measurement of pTau 217 in CSF in only 35 minutes.

Goki Ishikawa, President and CEO of Fujirebio Holdings, said having pTau 217 CSF in Fujirebio’s neuro portfolio helps clinical researchers. They will then gain deeper insights to discriminate Alzheimer’s from other dementias early in the disease process.

This, Ishikawa said, provides “more confidence in biomarker results or answering specific clinical research questions—offering a more detailed picture.”

Addition to CSF Biomarker Portfolio

Before this launch, the company’s established biomarker panel already included pTau 217 plasma and other CSF biomarkers. Adding the assay to its portfolio will help Fujirebio advance associated research tools and diagnostics.

As for the LUMIPULSE G immunoassay analyzer, this is fully automated and random-access. It will give researchers access to convenient, accurate, and robust measurement of pTau 217 in CSF, as well as blood.

The analyzers are already widely available worldwide, for routine use in neurological disease testing.

Fujirebio is a wholly owned subsidiary of H.U. Group Holdings. Along with Alzheimer’s research, the company’s expertise more broadly includes neurology, oncology, and infectious diseases.