June 28, 2023—Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays have received FDA 510(k) clearance and will be available in Q4 2023.
The Abeta42 and tTau assays measure beta‑amyloid (1‑42) and total tau concentrations in CSF in adults ages 55 and older who are being evaluated for Alzheimer’s disease and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value. The ratio of these biomarkers (tTau/Abeta42) is consistent with a negative amyloid PET scan if the result is less than or equal to the cutoff and with a positive amyloid PET scan if the result is above the ratio cutoff. A positive tTau/Abeta42 ratio result in CSF does not establish a diagnosis of Alzheimer’s disease. The assays are intended to be used in addition to other clinical diagnostic evaluations to determine whether a person has Alzheimer’s.
The Elecsys Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) received FDA 510(k) clearance last year.