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Roche Secures CE Mark For First Blood Test To Identify ApoE4 Carriers In Alzheimer's Disease

Healthcare & BiotechProduct LaunchesRegulation & LegislationTechnology & InnovationCompany Fundamentals

Roche received CE Mark approval for the Elecsys ApoE4 test, the first in-vitro diagnostic immunoassay able to identify ApoE4 genetic variant carriers from a simple blood sample. The CE approval enables commercialization across CE-marking jurisdictions, bolstering Roche's diagnostics and genetic-testing capabilities and presenting modest incremental revenue potential for its diagnostics franchise.

Analysis

Roche received CE Mark approval for the Elecsys ApoE4 test, the first in-vitro diagnostic immunoassay able to identify ApoE4 genetic variant carriers from a simple blood sample. The CE approval enables commercialization across CE-marking jurisdictions, bolstering Roche's diagnostics and genetic-testing capabilities and presenting modest incremental revenue potential for its diagnostics franchise.

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