Oct 13 (Reuters) - Roche Diagnostics said on
Monday the U.S. Food and Drug Administration cleared its and
partner Eli Lilly's ( LLY ) 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 ( ESALF ) Leqembi and Eli Lilly's ( LLY ) 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.