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 ( LLY ).
* 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 ( ESALF ) Leqembi
and Eli Lilly's ( LLY ) 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.