Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays received FDA’s 510(k) clearance (also called pre-market notification) for early and accurate diagnosis of Alzheimer’s disease (AD). This assay pair measures the ratio of two biomarkers of AD viz., tau (tTau) and beta-amyloid (Abeta42). It will hit the market in Q4 of 2023 and is the second pair of Elecsys AD CSF assays from Roche for AD diagnosis. In 2022, FDA 510(k) cleared Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays and are already available for use. This combination measures the ratio of phosphorylated Tau-181 (pTau181) and beta-amyloid (Abeta42). Elecsys AD CSF assays are registered in 46 countries, including the European Union.
AD is a form of dementia characterized by aggregates of beta amyloid plaques and neurofibrillary tangles of tau protein. Accurate diagnosis of AD can take years. The only FDA-cleared methods to determine beta amyloid pathology are CSF tests and PET scan imaging. Elecsys AD CSF assays are consistent with amyloid PET scan imaging and anticipated to be more affordable and accessible routine option to detect both amyloid and tau biomarkers from one draw with no exposure to radiation. Success rate of accurately diagnose AD clinically is only 70-80%. While not confirmatory, these assays will serve as additional tests on top of clinical diagnostic evaluations for early detection of AD improving medical decisions.
