Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
XTalks
APRIL 18, 2024
The approval of amyloid-beta-targeting therapies like Leqembi and recently discontinued Aduhelm (aducanumab) have come with controversy around their clinical effectiveness. Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4).
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