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# FDA OKs Marketing of New Alzheimer’s Diagnostic
- URL: https://www.fdaweb.com/fda-oks-marketing-of-new-alzheimers-diagnostic/
- Published: 2022-05-04T12:00:00.000Z
- Updated: 2026-09-14T17:43:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151741

FDA is permitting marketing of Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test, the first *in vitro* diagnostic test for early detection of amyloid plaque associated with Alzheimer’s disease. An agency [announcement](https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-test-improve-diagnosis-alzheimers-disease?ref=fdaweb.com) says the test is intended to be used in adult patients, age 55 and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.