Dec. 8, 2022—Roche announced FDA 510(k) clearance of its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays. The assays measure beta-amyloid (1-42) and phospho-tau (181P) concentrations in cerebrospinal fluid in adults 55 and older who are being evaluated for Alzheimer’s disease and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value. The assays can detect Alzheimer’s pathology in earlier stages of disease (e.g. mild cognitive impairment) when changes in these biomarker levels occur. The ratio of the biomarkers (pTau181/Abeta42) is consistent with a negative beta-amyloid PET scan if the result is less than or equal to the cutoff and with a positive beta-amyloid PET scan if the result is above the ratio cutoff. Abeta42 and pTau181 assays are intended to be used in addition to other clinical diagnostic evaluations to determine whether a person has Alzheimer’s.
The Elecsys AD CSF assays will be available on Cobas fully automated immunoassay analyzers.