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.
• 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.
• The test has already received breakthrough device designation from the U.S. FDA.
• 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.
• Roche said an estimated 75% of people living with dementia remain undiagnosed.
• 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 by Marleen Kaesebier. Editing by Mark Potter)
