US Approval Granted for Roche and Lilly’s Alzheimer’s Blood Test
Roche Diagnostics recently announced a significant advancement in Alzheimer’s disease assessment. The U.S. Food and Drug Administration (FDA) has approved a new blood test developed in partnership with Eli Lilly, aimed at aiding the initial evaluation of Alzheimer’s. This approval marks a noteworthy progression in Alzheimer’s diagnostics, following the FDA’s earlier approval of Fujirebio Diagnostics’ blood test, Lumipulse, in May.
Details of the New Alzheimer’s Blood Test
The newly approved test, known as Elecsys, measures the levels of pTau181, a protein linked to Alzheimer’s disease. It is designed for patients aged 55 and older who exhibit signs of cognitive decline.
Advantages of Blood Testing
Blood tests for Alzheimer’s can expedite diagnostic processes and improve access to treatments. These treatments include Biogen’s Leqembi and Eli Lilly’s Kisunla, which may be challenging to access with traditional diagnostic methods. Conventional options, such as spinal taps or PET brain scans, are often invasive and costly.
- Spinal taps: Invasive procedures requiring a puncture to collect spinal fluid.
- PET scans: Expensive imaging tests that may not be covered by health insurance.
Analysts believe that blood-based diagnostics could facilitate more effective treatment adoption for Alzheimer’s drugs, which have faced criticism regarding their cost and efficacy. Notably, Biogen reported that increased utilization of blood tests improved patient access to Leqembi.
Clinical Efficacy and Infrastructure
In a clinical study involving 312 participants, Roche’s Elecsys achieved a remarkable 97.9% negative predictive value, effectively ruling out the presence of Alzheimer’s. Roche has positioned itself to seamlessly integrate this new test into healthcare facilities. With over 4,500 diagnostic machines operational across the United States, the company is prepared for rapid deployment.
This breakthrough in Alzheimer’s diagnostics provides hope for improved assessment and treatment strategies, benefiting patients and healthcare providers alike.
