Roche, Eli Lilly Alzheimer's Blood Test to Get Expedited FDA Review
By Adria Calatayud
Roche Holding said a blood test for earlier diagnosis of Alzheimer's disease it is developing together with Eli Lilly will get an expedited review by the U.S. Food and Drug Administration.
The Swiss pharmaceutical giant said Thursday that the Elecsys pTau217 test received the so-called breakthrough device designation from the FDA, a program designed to accelerate development and review of medical devices.
Roche said the test relies on a biomarker that has shown the ability to distinguish Alzheimer's disease from other neurodegenerative disorders and strong performance relative to other biomarkers in research settings.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
April 11, 2024 01:33 ET (05:33 GMT)
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