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Roche, Lilly's blood test for Alzheimer's diagnosis gets US approval
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Roche, Lilly's blood test for Alzheimer's diagnosis gets US approval
Oct 13, 2025 8:00 AM

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.

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