H.U. Group Holdings Inc. announced availability of the Lumipulse G ß-Amyloid 1-42 Plasma and Lumipulse G ß-Amyloid 1-40 Plasma assays for the fully automated LUMIPULSE G immunoassay systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of ß-amyloid1-42 and ß-amyloid1-40 in human plasma within just 35 minutes. The two new automated blood-based biomarker assays are available for research use only. They will allow researchers and clinical research professionals across the world to further study the clinical utility of the Aß1-42, Aß1-40 and the pTau 181 markers in Alzheimer's disease and related disorders on the LUMIPULSE G platform.

This platform has the required through put and meets the regulatory requirements to support possible future routine use of blood-based testing of these markers. The Lumipulse G ß-Amyloid 1-42 Plasma and the Lumipulse G ß-Amyloid 1-40 Plasma assays, together with the already available Lumipulse G pTau 181 plasma assay, complement the panel of four key cerebrospinal fluid assays (Aß1-42, Aß1-40, tTau and pTau 181) already available within the Lumipulse G as well as the INNOTEST Neuro product portfolio. 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 Alzheimer's disease. Current research indicates that the plasma ß-amyloid1-42/ß-amyloid1-40 ratio has the potential to be used in clinical settings and within clinical trials to predict brain ß-amyloid burden.1-2 It could also be used as a tool to evaluate target engagement and efficacy of disease-modifying drugs.3 The development of the Lumipulse G ß-Amyloid 1-42 Plasma and Lumipulse G ß-Amyloid 1-40 Plasma assays has been supported by the Flanders Innovation & Entrepreneurship.