Swiss drug major Roche Holding AG (RHHBY) announced Wednesday that it has entered into a collaboration to support the development of Elecsys Amyloid Plasma Panel or EAPP with Eli Lilly and Co. (LLY). The move is expected to enhance early diagnosis of Alzheimer's disease.
The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer's disease. The EAPP has demonstrated clinical performance and is currently undergoing additional investigation to ensure clinical validation.
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, the company also received FDA 510(k) clearance for its Elecsys beta-Amyloid and Elecsys Phospho-Tau assays, which identify Alzheimer's pathology in its early symptomatic stage.
Matt Sause, CEO of Roche Diagnostics, said, "Today, over 55 million people are living with dementia and this is projected to increase to nearly 140 million by 2050. Collaboration is essential to ensure these people receive a timely and accurate diagnosis. The Elecsys Amyloid Plasma Panel has the potential to streamline a person's journey to diagnosis and, therefore, access to future treatment options."
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