Roche announced that it has entered into a collaboration with Eli Lilly to support the development of Roche’s Elecsys Amyloid Plasma Panel (EAPP).
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The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease.
Today, barriers to early and accurate diagnosis of Alzheimer’s exist across the globe with up to 75% of people living with the symptoms of Alzheimer’s, but without a diagnosis. Those who have received a diagnosis waited, on average, 2.8 years after symptom onset.
To address the growing strain that Alzheimer’s is putting on healthcare systems, it will be essential to make a person's journey to diagnosis faster and more accessible. This will ultimately enable access to appropriate new therapies as they become available.
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.
In July, Roche announced that the U.S. Food and Drug Administration granted the EAPP Breakthrough Device Designation.
In December 2022, Roche also received FDA 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays, which identify Alzheimer's pathology in its early symptomatic stage.
The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma.
Elevations in pTau181 occur in early stages of Alzheimer’s, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease.
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. ■