Roche's Elecsys Alzheimer's Diagnostic Test Kits Receive FDA 510(k) Clearance

Roche announced on December 8 that its Elecsys β-Amyloid (1-42) and Elecsys Phospho-Tau (181P) CSF assay kits had received 510(k) clearance from the U.S. Food and Drug Administration (FDA). These are two assay kits for adults aged 55 and over who are being evaluated for Alzheimer's disease. Roche's Elecsys AD CSF assay kits have been registered in 45 countries worldwide, including those that accept the EU CE mark.