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# 2 Roche Alzheimer’s Tests Cleared by FDA
- URL: https://www.fdaweb.com/2-roche-alzheimers-tests-cleared-by-fda/
- Published: 2022-12-09T12:00:00.000Z
- Updated: 2026-09-14T18:09:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153367

FDA has granted Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181), assays that measure two Alzheimer’s Disease biomarkers — beta-amyloid and tau proteins — in adults aged 55 years and older. The company says the assays achieve 90% concordance with 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.”