Fujirebio Launches Automated pTau 217 CSF Assay for Alzheimer's Disease Research
核心洞察
Fujirebio (搜索) has launched the Lumipulse G pTau 217 (搜索) CSF assay for research use, enabling quantitative measurement of phosphorylated tau (搜索) protein in cerebrospinal fluid within 35 minutes.
The assay targets pTau 217 (搜索), an early biomarker for neuropathological changes associated with Alzheimer's disease (搜索), potentially improving discrimination between AD and non-AD dementias.
The fully automated LUMIPULSE G platform provides researchers with convenient access to robust pTau 217 (搜索) measurement in both CSF and blood samples on a single system.
H.U. Group Holdings Inc. (搜索) and its wholly-owned subsidiary Fujirebio (搜索) announced the availability of the Lumipulse G pTau 217 (搜索) CSF assay for the fully automated LUMIPULSE® G immunoassay analyzers on January 28, 2026. This chemiluminescent enzyme immunoassay (CLEIA) is available for Research Use Only (RUO) and enables quantitative measurement of Tau (搜索) phosphorylated at threonine 217 (pTau 217) in human cerebrospinal fluid within 35 minutes.
Targeting Early Alzheimer's Biomarkers
Alzheimer's disease (搜索) is characterized by the accumulation of neurofibrillary tangles in the brain, composed of hyperphosphorylated tau (搜索), and amyloid plaques, consisting of distinct β-amyloid (搜索) peptides. CSF pTau217 has emerged as an early biomarker for neuropathological changes associated with AD, according to the company announcement.
"By adding pTau 217 (搜索) CSF to our neuro portfolio, clinical researchers can gain deeper insights into its potential to discriminate AD from non-AD dementias early in the disease process," said Goki Ishikawa, President and CEO of Fujirebio (搜索) Holdings, Inc.
Enhanced Diagnostic Portfolio
The new immunoassay strengthens Fujirebio (搜索)'s growing portfolio of neurological biomarkers and reinforces the company's position in advancing research tools and diagnostics. Ishikawa noted that "pTau 217 (搜索) CSF complements our established biomarker panel, including pTau 217 Plasma and other CSF biomarkers, by allowing an even earlier detection of proteins associated with AD-related pathology, providing more confidence in biomarker results or answering specific clinical research questions - offering a more detailed picture of the disease on a single platform."
Automated Platform Advantages
The availability of the assay on the fully automated random-access LUMIPULSE G analyzers provides researchers access to convenient, accurate, and robust measurement of pTau 217 (搜索) in CSF, in addition to blood. These analyzers are already widely available for routine use in neurological disease testing worldwide and meet all necessary quality, throughput, and regulatory requirements.
Company Background
Fujirebio (搜索) is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide. Part of H.U. Group, the company leverages expertise in neurology, oncology, infectious diseases, and other areas through assays available on the Lumipulse® platform. Fujirebio's open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry, combining strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions.