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www.fdanews.com/articles/211598-lilly-and-roche-collaborate-on-blood-test-for-early-detection-of-alzheimers

Lilly and Roche Collaborate on Blood Test for Early Detection of Alzheimer’s

March 24, 2023

Roche has teamed up with Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), an investigational blood-based biomarker test designed to give patients an earlier Alzheimer’s disease diagnosis.

The test panel looks for elevated levels of two proteins associated with the early stages of the disease — phosphorylated Tau and apolipoprotein — identifying the likelihood that symptomatic patients have the disease.

Alzheimer’s is the most common form of dementia, but patients wait an average of 2.8 years to be diagnosed after symptoms begin, Roche noted. Currently, the diagnosis of Alzheimer’s disease is largely based on clinical symptoms, including cognitive assessment, with a significant number of patients diagnosed when their disease has already advanced.

Roche received FDA’s Breakthrough Device designation for the panel last July, which gives it a fast track through the development and regulatory review process.

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