Roche Wins FDA Breakthrough Device Designation For Alzheimer’s Test

Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.

Alzheimer's
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Roche Corp.’s Elecsys pTau217 plasma biomarker test, which has been granted US Food and Drug Administration breakthrough device designation and was developed in partnership with Eli Lilly and Company, helps identify the presence or absence of amyloid pathology of Alzheimer’s disease.

PTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has been shown in a research...

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