Roche granted FDA clearance for additional Alzheimer’s disease CSF assays

Roche’s Elecsys beta-Amyloid CSF II and Elecsys Total-Tau CSF assays have received FDA 510(k) clearance. The Elecsys AD CSF Abeta42 and tTau assays measure two biomarkers of Alzheimer’s pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease. The FDA-cleared Elecsys tTau/Abeta42 ratio supports timely Alzheimer’s disease diagnosis and treatment decision-making, and expands Roche’s AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer’s: amyloid plaques, tau tangles and neurodegeneration. The only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scan imaging. The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain. They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease.