H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio 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 Alzheimer's disease (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 (Aß1-42, Aß1-40, 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 development of the Lumipulse G pTau 181 Plasma assay will be accelerated with support from the Diagnostics Accelerator at the Alzheimer's Drug Discovery Foundation (ADDF) and Flanders Innovation & Entrepreneurship (VLAIO).