GENT, Belgium & MALVERN, PA & TOKYO, Japan — A new laboratory test aimed at detecting Alzheimer’s disease earlier in its progression is now available to researchers, marking a potential advance in the race to identify the disease before symptoms fully emerge.
H.U. Group Holdings and its wholly owned subsidiary Fujirebio announced the release of the Lumipulse G pTau 217 cerebrospinal fluid assay, a fully automated test designed to measure a key Alzheimer’s biomarker in just 35 minutes. The assay runs on Fujirebio’s LUMIPULSE G immunoassay analyzers and is currently available for research use only.
The test targets tau protein phosphorylated at threonine 217, known as pTau 217, which has emerged as an early indicator of the neurodegenerative changes associated with Alzheimer’s disease. Alzheimer’s is marked by the buildup of amyloid plaques and neurofibrillary tangles in the brain, with abnormal tau proteins playing a central role in disease progression.
Company officials said the new assay strengthens Fujirebio’s growing portfolio of neurological biomarkers and supports efforts to distinguish Alzheimer’s disease from other forms of dementia earlier and with greater confidence.
“By adding pTau 217 CSF to our neuro portfolio, clinical researchers can gain deeper insights into its potential to discriminate Alzheimer’s disease from non-Alzheimer’s dementias early in the disease process,” said Goki Ishikawa, president and CEO of Fujirebio Holdings. He said the assay complements existing plasma and cerebrospinal fluid biomarkers, helping researchers build a more detailed picture of disease pathology using a single testing platform.
The assay is designed for use on Fujirebio’s fully automated, random-access LUMIPULSE G analyzers, which are already used worldwide for neurological disease testing. The company said the systems meet established quality, throughput, and regulatory standards and allow for accurate measurement of pTau 217 in both cerebrospinal fluid and blood.
While the test is not yet approved for clinical diagnosis, researchers view tools like pTau 217 as critical to advancing early detection strategies and accelerating the development of treatments for Alzheimer’s disease, which affects millions of people globally and remains without a cure.
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