Lumipulse^® G ADxPLORER^® pTau231

pTau231 is one of the earliest phospho-epitopes detected in the brains of Alzheimer’s disease (AD) patients, including at pre-symptomatic stages. In cerebrospinal fluid (CSF), pTau231 was sensitive to the earliest changes of Aβ in the medial orbitofrontal, precuneus and posterior cingulate before global Aβ PET positivity was reached¹. In blood-based studies, particularly in plasma, pTau231 has emerged as a promising early marker of AD pathology. In research studies, pTau231 has been shown to identify individuals below the PET threshold for amyloid-β positivity^2,3. Moreover, plasma pTau231, together with pTau181 and pTau217, and [18F]MK6240 appear to reflect different stages of tau pathology progression⁴, however its clinical utility remains to be further established.

The Lumipulse® G ADxPLORER® pTau231 assay was developed using a proprietary pTau231 monoclonal antibody ADx257 (90571) in conjunction with an alkaline phosphatase-conjugated Fab fragment derived from recombinant mAb ADx218 (90563). The assay is calibrated with a peptide containing the epitope of ADx257 and ADx218.

 
References:

1. Ashton et al. Cerebrospinal fluid p-tau231 as an early indicator of emerging pathology in Alzheimer's disease. EBioMedicine. 2022 Feb;76:103836.
2. Ashton et al. Plasma p-tau231: a new biomarker for incipient Alzheimer's disease pathology. Acta Neuropathol. 2021 May;141(5):709-724.
3. Milà-Alomà et al. Plasma p-tau231 and p-tau217 as state markers of amyloid-β pathology in preclinical Alzheimer's disease. Nat Med. 2022 Sep;28(9):1797-1801. Epub 2022 Aug 11. Erratum in: Nat Med. 2022 Sep;28(9):1965.
4. Tissot et al. Comparing tau status determined via plasma pTau181, pTau231 and [18F]MK6240 tau-PET. EBioMedicine. 2022 Feb;76:103837.

Lumipulse is a registered trademark of Fujirebio Inc.
ADxPLORER is a registered trademark of Fujirebio Europe NV.