ZURICH (Reuters) – The U.S. Food and Drug Administration has granted Roche an accelerated review for its Elecsys product used to diagnose Alzheimer’s disease, the Swiss drugmaker said on Friday.
The FDA gave breakthrough device designation to Elecsys, which examines the cerebrospinal fluid in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia.
(Reporting by John Revill; Editing by Amrutha Gayathri)
