May 16 (Reuters) - The U.S. Food and Drug Administration

has cleared Fujirebio Diagnostics' blood test to diagnose

Alzheimer's disease, the regulator said on Friday, making the

device the first of its kind to detect the brain-wasting

condition.

Blood tests could speed up diagnosis of the disease and make

it easier for more people to access its treatments such as

Biogen and Eisai's ( ESALF ) Leqembi and Eli Lilly's ( LLY )

Kisunla, since traditional tests are often costly or

uncomfortable.

Fujirebio's test, branded as Lumipulse, checks for two

proteins in the blood and uses their ratio to help detect signs

of amyloid beta plaque, considered a hallmark of the disease, in

the brain.

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.

"Street expectations for both therapies (Leqembi and

Kisunla) are modest" with a slow ramp over the next few years,

given the lack of access to neurologists, said Citi analyst

Geoffrey Meacham. "An approved blood-based diagnostic is a

positive in a disease area that has been starved of

game-changing innovation."

Biogen has been doubling down on Leqembi but it has failed

to live up to lofty expectations due to concerns over cost,

efficacy and side effects.

In the first quarter, Leqembi brought $96 million in sales,

while Lilly recorded $21.5 million in Kisunla sales.

Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two

performers when compared with four other commercial blood tests

for Alzheimer's, according to a study led by researchers at

Washington University School of Medicine.

Biogen has partnered with Fujirebio, and Eisai ( ESALF ) is

collaborating with C2N to clinically advance and commercialize

blood tests that can detect Alzheimer's risk.