Roche Alzheimer’s disease cerebrospinal fluid (CSF) assays receive FDA clearance

Dec. 9, 2022
Clearance supports a timelier diagnosis of Alzheimer's.

Roche announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer’s pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease. 

The Elecsys AD CSF assays achieve 90% concordance with the Amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid in the brain. They also offer detection of multiple biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease.

Due to the large installed base of instruments, the Elecsys AD CSF assays are easily scalable to meet the imminent demand that these therapies will generate as they become available. 

Roche release