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# Roche/Lilly Collaborate on Alzheimer’s Test
- URL: https://www.fdaweb.com/roche-lilly-collaborate-on-alzheimers-test/
- Published: 2023-03-22T12:00:00.000Z
- Updated: 2026-09-14T18:21:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154044

Roche and Eli Lilly are collaborating to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), a blood test designed for making earlier diagnoses of Alzheimer’s disease. “If approved, the EAPP test would be an additional tool to identify low likelihood of amyloid pathology in symptomatic patients and determine whether they should proceed to further evaluation and testing that may confirm a diagnosis,” the companies say.

FDA last year granted EAPP a breakthrough device designation. In December, Roche obtained 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF assays, which are intended to identify Alzheimer’s pathology in its early symptomatic stage.

The Elecsys Amyloid Plasma Panel is being designed to measure phosphorylated Tau (pTau) 181 protein and apolipoprotein E4 in human blood plasma. “Elevations in pTau181 occur in early stages of Alzheimer’s, while the presence of \[apolipoprotein E4\] constitutes the most common genetic risk factor for Alzheimer’s disease,” the companies say. “The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.”