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# 2 Roche Assays Cleared for Alzheimer’s
- URL: https://www.fdaweb.com/2-roche-assays-cleared-for-alzheimers/
- Published: 2023-06-29T12:00:00.000Z
- Updated: 2026-09-14T18:41:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154804

FDA has cleared two Roche assays that measure two biomarkers of Alzheimer's pathology — beta-amyloid and tau proteins — in adults over 55 being diagnosed with Alzheimer’s disease. The [Elecsys beta-Amyloid (1-42) CSF II (Abeta42)](https://c212.net/c/link/?t=0&l=en&o=3904782-1&h=2700850106&u=https%3A%2F%2Fdiagnostics.roche.com%2Fus%2Fen%2Fproducts%2Fparams%2Felecsys-abeta42.html&a=Elecsys%C2%AE+beta-Amyloid+%281-42%29+CSF+II+%28Abeta42%29&ref=fdaweb.com) and [Elecsys Total-Tau CSF (tTau)](https://c212.net/c/link/?t=0&l=en&o=3904782-1&h=4106889044&u=https%3A%2F%2Fdiagnostics.roche.com%2Fus%2Fen%2Fproducts%2Fparams%2Felecsys-ttau.html&a=Elecsys%C2%AE+Total-Tau+CSF+assays+%28tTau%29&ref=fdaweb.com) assays “can detect Alzheimer’s pathology in earlier stages of disease (e.g., mild cognitive impairment),” the company says. “Abeta42 and tTau assays are intended to be used in addition to other clinical diagnostic evaluations to determine whether a person has Alzheimer’s. A positive tTau/Abeta42 ratio result in \[*cerebrospinal fluid\]* CSF does not establish a diagnosis of Alzheimer's disease.”