Roche Gains CE Mark for Advanced Blood Test Targeting Alzheimer’s Disease
Roche Receives European Approval for New Alzheimer’s Blood Test
Regulatory Clearance and Collaboration
ZURICH, May 12 (Reuters) - Swiss drugmaker Roche has received the CE mark - a European regulatory clearance allowing sale in the region - for its second Elecsys blood test for Alzheimer's disease, it said on Tuesday.
The test was developed with U.S. company Eli Lilly.
Features and Benefits of the pTau217 Test
Comparison with Previous Tests
• Compared with its already approved pTau181 test, which mainly helps rule out Alzheimer's-related amyloid pathology, the newer pTau217 test can both help confirm and exclude the disease. It is validated for use in both primary and specialist care.
Regulatory Status in the United States
• The test has already received breakthrough device designation from the U.S. FDA.
Potential Impact on Diagnosis and Treatment
• Blood tests could speed diagnosis and widen access to treatments such as Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, as current diagnostic methods are often costly or uncomfortable.
Addressing the Diagnosis Gap
• Roche said an estimated 75% of people living with dementia remain undiagnosed.
Availability Timeline
• The test is expected to become available in CE-marked markets from July, Olivier Gillieron, life cycle leader in cardiometabolic and neurology at Roche told media in a call.
Reporting and Editorial Credits
(Reporting by Marleen Kaesebier. Editing by Mark Potter)
