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Roche Nabs FDA Clearance for Alzheimer's Assays

NEW YORK – Roche said Tuesday that it secured US Food and Drug Administration 510(k) clearances for a pair of assays to aid diagnosis of Alzheimer's disease measuring levels of beta-amyloid and tau proteins. 

The Basel, Switzerland-based firm's Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays are used together to provide the ratio of tTau and Abeta42 proteins in evaluating adults ages 55 and older for Alzheimer's disease. Roche also received clearance in December 2022 for use of the Abeta42 assay and its Elecsys Phospho-Tau (181P) CSF immunoassay, which are used together to identify a patient's ratio of Abeta42 and pTau181 proteins. 

Roche said Tuesday the ratios measured with the assays reflect the main Alzheimer's pathologies of amyloid plaques, tau tangles, and neurodegeneration, and the assays can help clinicians more completely define a patient's disease. Changes in the biomarker levels also can help identify Alzheimer's pathology in earlier stages. 

The Abeta42 and pTau181 assays are available and the tTau and Abeta42 assay combination will be available in the fourth quarter of 2023, the firm said. The assays are designed for use on Roche's fully automated Cobas immunoassay instruments. 

"An early and accurate diagnosis can help patients, caregivers, and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective," Roche Diagnostics North America CEO Brad Moore said in a statement. 

The firm noted that the Abeta42 and tTau assays are intended to be used along with other clinical evaluations. 

The firm said its Elecsys AD CSF assays are concordant with amyloid PET scan imaging and can provide a more affordable, accessible routine method of confirming amyloid pathology through a single CSF draw. The assays are CE marked and registered in a total of 46 countries. Roche also secured FDA breakthrough device designation in 2022 for its Elecsys Amyloid Plasma Panel for measuring Alzheimer's biomarkers from blood samples, although those assays remain under development.