Roche and Eli Lilly Receive U.S. FDA Approval for Alzheimer’s Blood Test
Roche Diagnostics announced on Monday that the U.S. Food and Drug Administration (FDA) has cleared its Elecsys blood test, developed in partnership with Eli Lilly, as an aid for the initial assessment of Alzheimer’s disease.
The approval follows the FDA’s earlier decision in May to authorize Fujirebio Diagnostics’ Lumipulse, the first blood test ever approved to help diagnose the neurodegenerative condition.
Roche’s Elecsys test works by measuring pTau181, a key protein linked to Alzheimer’s disease progression. It is designed for patients aged 55 and older who show signs of memory loss or cognitive decline.
Experts believe that blood-based Alzheimer’s tests could revolutionize diagnosis by speeding up detection and making it easier for patients to access treatments such as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla. These tests offer a more convenient and affordable alternative to traditional diagnostic methods, which often include spinal taps or PET brain scans that are either invasive or costly.
Analysts note that the rise of blood diagnostics could improve adoption rates for Alzheimer’s drugs, which have faced slow rollouts due to pricing, safety, and efficacy concerns.
In July, Biogen reported that wider use of blood-based testing has already helped increase the uptake of Leqembi, its Alzheimer’s treatment.
Roche said its clinical study of 312 participants demonstrated that Elecsys could rule out Alzheimer’s with a 97.9% negative predictive value, making it a highly reliable tool for early assessment.
With over 4,500 diagnostic machines already installed in laboratories across the United States, Roche stated it is well-positioned to deploy Elecsys nationwide, integrating it seamlessly into existing clinical systems.
