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Roche, Eli Lilly Collaborate on Blood Test to Aid Early Diagnosis of Alzheimer's

NEW YORK – Roche said Wednesday that it has entered a collaboration with drug maker Eli Lilly to support development of Roche's Elecsys Amyloid Plasma Panel (EAPP), a blood test for aiding earlier diagnosis of Alzheimer's disease.

The panel measures phosphorylated tau 181 (pTau) protein and apolipoprotein E4 in plasma to help determine whether an individual is at high risk of Alzheimer's disease. Patients with a positive result could then be referred for additional confirmatory testing via methods including amyloid PET testing or cerebrospinal fluid testing.

There is great interest in blood-based tests for Alzheimer's as such assays could provide a less expensive and invasive way to screen patients for early signs of the disease, which could help both in patient treatment and recruiting individuals for drug trials for anti-Alzheimer's therapies.

"We are excited to be collaborating with Lilly on such an important area of unmet medical need," Roche Diagnostics CEO Matt Sause said in a statement. "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."

"We are pleased to be joining Roche to support the development of yet another potential diagnostic tool," Mark Mintun, Lilly group vice president of neuroscience R&D and president of Avid Radiopharmaceuticals, said in the statement. "We look forward to the robust data and continued collaboration across the field that will be critical to accelerate the ecosystem to aid in a timely and accurate diagnosis of Alzheimer’s."

Last year, the US Food and Drug Administration granted the EAPP Breakthrough Device Designation.

In December 2022, Roche received FDA 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays, which measure these proteins in cerebrospinal fluid to identify Alzheimer's pathology.

Financial and other terms of the agreement were not disclosed.