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NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has granted breakthrough device designation to two of its Elecsys cerebrospinal fluid in vitro diagnostic immunoassays for Alzheimer's disease.

The assays, Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF, are used to measure beta-amyloid and phospho-tau peptide concentrations, respectively, in the CSF of patients with cognitive impairment who are evaluated for Alzheimer's disease or other causes of dementia.

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