New CSF Assays to Measure Beta-Amyloid and Tau Receive Clearance from FDA

Roche (Basel, Switzerland) announced that the US Food and Drug Administration (FDA) has issued 501(k) clearance to assays that measure 2 biomarkers, beta-amyloid and tau proteins, used to evaluate Alzheimer disease (AD) pathology based on the cerebrospinal fluid (CSF) of adults aged 55 and older. These are the Elecsys beta-Amyloid (1-42) CSF II assay (Abeta42) and the Elecsys Total-Tau CSF assay (tTau), used as a tTau/Abeta42 ratio. The new assays add to Roche’s already available Elecsys Abeta42 and Elecsys Phospho-Tau (181-P) CSF (pTau181) assays, used as a pTau181/Abeta42 ratio, which received 501(k) clearance in 2022. The Elecsys assays will be available on cobas modular analyzer systems. 

Data provided by Roche in their announcement indicate that the results from the Elecsys CSF assays were 90% concordant with results obtained through amyloid positron emission tomography (PET) scan imaging tests. The company reports that the assays will be available commercially in 2023.

"With the increasing likelihood of broad availability of new, Alzheimer's disease–specific therapies, now is the time for healthcare professionals and institutions to prepare to meet the demand for diagnostic methods to streamline and accelerate the path to the right treatment, at the right time, for people with Alzheimer's," said Brad Moore, President and CEO of Roche Diagnostics North America.