Roche and Eli Lilly will join forces on the development of Roche’s Elecsys Amyloid Plasma Panel, a blood test that aims to facilitate the early diagnosis of Alzheimer’s disease, Roche said on Wednesday.
The test, if approved, could help determine whether patients should receive further evaluation that may confirm a diagnosis and could help them access new therapies as they become available, the company said.
Up to 75% of people living with symptoms of Alzheimer’s disease lack a diagnosis, while patients with a diagnosis typically received one 2.8 years after the onset of symptoms, the company said.
The test has demonstrated clinical performance and is undergoing additional investigation to ensure clinical validation, Roche said.
Roche announced in July that the U.S. Food and Drug Administration granted the test its breakthrough device designation. In December, Roche gained FDA 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF assays that identify Alzheimer's pathology in its early symptomatic stage.
"We are pleased to be joining Roche to support the development of yet another potential diagnostic tool,” Mark Mintun, Lilly group vice president for neuroscience R&D, said in a 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."
The collaboration comes after Lilly earlier this month announced it would halt testing of solanezumab, once its top Alzheimer’s drug candidate, after 20 years of research because the treatment showed no benefit in a clinical trial.