(Reuters) -Roche Diagnostics said on Monday the U.S. Food and Drug Administration cleared its and partner Eli Lilly’s blood test as an aid in the initial assessment for Alzheimer’s disease.
This comes at the heel of FDA’s nod for Fujirebio Diagnostics’ blood test Lumipulse in May, the first such device to get approval to diagnose the brain-wasting condition.
Roche’s test Elecsys measures pTau181, a key protein associated with Alzheimer’s disease. It is intended for patients ages 55 and older presenting signs, symptoms or complaints of cognitive decline.
Blood tests could speed up diagnosis of the disease and make it easier to access treatments such as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla, since traditional tests are often costly or uncomfortable.
Other options to detect Alzheimer’s include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers.
Analysts have said blood-based diagnostics could be positive for Alzheimer’s drugs that have been facing slow starts due to concerns over cost, efficacy and side effects.
In July, Biogen said improved rates of blood tests to diagnose the memory-robbing condition have helped with the uptake of Leqembi.
In a clinical study with 312 participants, Elecsys was able to rule out Alzheimer’s with a 97.9% negative predictive value, said Roche.
The company said it has more than 4,500 diagnostic machines already installed in clinical laboratories across the U.S., making it well-positioned to rapidly integrate the blood test into its existing infrastructure.
(Reporting by Christy Santhosh in Bengaluru; Editing by Sahal Muhammed)
