Fujirebio Launches Neurodegeneration Assay for Automated Blood-Based Alzheimer’s Disease Biomarker Testing

Fujirebio has announced the availability of the Lumipulse G pTau 181 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 181 in human plasma within just 35 minutes. With the launch of this new neurodegeneration assay, automated blood-based biomarker testing for AD, and testing for plasma pTau 181 in particular, may soon transition from research to clinical routine. The assay is available for research use only and will allow researchers and clinical research professionals to further study the clinical utility of this marker on the Lumipulse platform that has the required throughput and meets the regulatory requirements to support possible future routine use.

The Lumipulse G pTau 181 Plasma assay complements the panel of four key cerebrospinal fluid (CSF) assays (Aβ1-42, Aβ1-40, tTau and pTau 181) already available on the LUMIPULSE G platform. These four CSF parameters can provide essential information on the presence of amyloid and tau pathology in neurodegenerative disease. There is hope that blood-based testing can become an even simpler, more accessible, and more scalable approach to help support the diagnosis of AD. The plasma pTau 181 marker also has the potential to further advance the development of disease-modifying treatments by streamlining patient eligibility for clinical trials and monitoring of patients on such future treatments

“The projected increase in the number of people suffering from dementia1 poses significant public health challenges worldwide, of which early diagnosis will be of particular importance,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “Fujirebio is rising to this challenge with the availability of a fully automated plasma pTau 181 assay on our well recognized LUMIPULSE G platform. This breakthrough opens another new chapter in the field of neurodegeneration testing.”

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