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FDA Grants Breakthrough Designation to Roche's Elecsys CSF Immunoassays for Alzheimer's Disease

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.

"We are excited about FDA's recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories, and their patients in diagnosing AD at an early stage," said Roland Diggelmann, CEO of Roche Diagnostics, in a statement. "Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions."

Alzheimer's disease is currently primarily diagnosed based on clinical symptoms, and measuring biomarkers in CSF that are associated with the disease increases the certainty of the diagnosis, Roche said.

The company offers three CE-marked CSF immunoassays to help in the early detection of Alzheimer's by clinicians: the Elecsys beta-Amyloid (1-42) CSF, the Elecsys Phospho-Tau (181p) CSF, and the Elecsys Total-Tau CSF. The markers measured by these tests can be used alone or in combination.