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# Roche Alzheimer’s Test is Breakthrough Device
- URL: https://www.fdaweb.com/roche-alzheimers-test-is-breakthrough-device/
- Published: 2024-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:28:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156757

FDA has given a breakthrough device designation to Roche’s Elecsys pTau217 plasma biomarker test that it is developing with Lilly to aid healthcare providers in identifying amyloid pathology, a feature of Alzheimer’s disease. A Roche [statement](https://www.roche.com/media/releases/med-cor-2024-04-11?ref=fdaweb.com) describes pTau217 as a phosphorylated fragment of the protein tau that is a biomarker that has shown the ability in research settings to distinguish Alzheimer’s disease from other neurodegenerative disorders and has shown strong performance relative to other biomarkers. The statement says the test is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of pTau217 in human plasma from individuals aged 60 and older.