Roche receives FDA clearance for additional Alzheimer’s disease Cerebrospinal Fluid (CSF) assays, supporting timely diagnosis and treatment decision-making

June 28, 2023
Elecsys AD CSF assays can be added to any of Roche’s cobas fully automated immunoassay analyzers, giving patients broad access to high-quality testing in a timely manner.

Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) measure two biomarkers of Alzheimer’s pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.

Roche’s FDA-cleared Alzheimer’s tests in the U.S. include two ratios comprising three assays. Both ratios include Abeta42. The Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022 and Elecsys beta-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF assays (the tTau/Abeta42 ratio) are reflective of the main Alzheimer’s pathologies and help clinicians more completely define the disease biologically, facilitating a diagnosis of inclusion.

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. The high cost, limited availability and patient exposure to radioactivity limit use and accessibility to PET. In addition, evaluating both amyloid and tau Alzheimer’s biomarkers using PET requires multiple appointments and procedures, and increases radiation exposure. 

The Elecsys pTau181/Abeta42 ratio is currently available. The new Elecsys tTau/Abeta42 ratio will be available in Q4 2023.

Roche release