Fujirebio Expands Its Neuro Testing Portfolio With the Launch of the Fully Automated Lumipulse® G pTau 217 CSF Assay for Research Use Only

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 CSF assay for the fully automated LUMIPULSE® G immunoassay analyzers. This CLEIA (chemiluminescent enzyme immunoassay) assay is available for Research Use Only (RUO) and allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human cerebrospinal fluid (CSF) within just 35 minutes.

Alzheimer’s disease (AD) is characterized by the accumulation of neurofibrillary tangles in the brain, composed of hyperphosphorylated tau, and amyloid plaques, consisting of distinct β-amyloid peptides. CSF pTau217 has emerged as an early biomarker for neuropathological changes associated with AD.

This new immunoassay further strengthens Fujirebio’s growing portfolio of neurological biomarkers and reinforces the company’s leading position in the advancement of associated research tools and diagnostics.

“By adding pTau 217 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 Holdings, Inc. “pTau 217 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.”

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 in CSF, in addition to blood. Already widely available for routine use in neurological disease testing worldwide, these analyzers meet all necessary quality, throughput, and regulatory requirements.

About Fujirebio

Fujirebio is a diagnostics company with over 75 years of experience delivering innovative solutions to healthcare providers, pharmaceutical companies, and IVD partners worldwide.

Leveraging world-class expertise in neurology, oncology, infectious diseases, and beyond, and assays available on the robust Lumipulse® platform, Fujirebio’s open business model accelerates access to breakthrough diagnostics through strategic partnerships across the life science industry.

Part of H.U. Group, Fujirebio combines strong R&D capabilities, regulatory expertise, and scalable manufacturing to deliver high-impact diagnostic solutions. Fujirebio’s flexible CDMO model helps its diagnostic partners bring validated solutions to the market faster— driving better decisions, treatments, and patient outcomes.

More information can be found at www.fujirebio.com/alzheimer.

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