Roche announced on Monday that it and Eli LillyElecsys, a blood test for Alzheimer's disease developed in collaboration with the two companies, has been approved for marketing by the U.S. Food and Drug Administration (FDA).
(Source: Company website)
The Elecsys test is reportedly suitable for patients aged 55 and above who have signs, symptoms or complaints of cognitive decline. It helps determine whether a patient has Alzheimer's disease by measuring the level of phosphorylated Tau (pTau) 181 protein in plasma.
Earlier in May, the FDA approved an Alzheimer's disease blood test kit from Japan's Fujirebio Diagnostics, which was the first product of its kind to be approved.
The blood test could speed up the diagnosis of Alzheimer's disease　　compared with traditional methods , including a lumbar puncture to collect cerebrospinal fluid and PET brain scans, which are expensive and may not be covered by health insurance.
In a clinical trial involving 312 participants, Elecsys was able to rule out Alzheimer's disease pathology with a negative predictive value (NPV) of 97.9%. This test can be fully automated with Roche's existing testing instruments, facilitating scalable testing.
Data shows that highly complex Alzheimer's disease affects more than 7 million patients in the United States, but as many as 92% of patients with mild cognitive impairment go undiagnosed , missing the opportunity to use a series of new drug interventions.
“By bringing blood-based biomarker testing for Alzheimer’s disease to primary care, we can help patients and their clinicians get answers faster, providing support earlier in the disease process,” said Brad Moore, president and CEO of Roche Diagnostics North America.
Therefore, blood tests like Elecsys can significantly expand the number of potential patients who receive testing, while also reducing the number of tests that discourage patients from seeking treatment, such as PET and cerebrospinal fluid testing, allowing for more efficient allocation of specialist resources. From a capital market perspective, accelerated disease diagnosis also allows patients to more easily access treatments such as Biogen/Eisai's Leqembi and Eli Lilly's Kisunla. These drugs have faced slow adoption since their launch.
Biogen said in July that increasing rates of blood testing for Alzheimer's disease would help drive adoption of Leqembi.
In addition to receiving FDA approval, Elecsys also received the European CE Mark certification in July this year, making it the first in vitro diagnosticA blood test approved under IVDR that can be used to help rule out amyloid pathology associated with Alzheimer's disease.
https://finance.eastmoney.com/a/202510143532708573.html