Augurex Life Sciences Granted FDA Breakthrough Designation for SPINEstat®, its First-in-Class Diagnostic Test for Axial Spondyloarthritis
Executive Summary The U.S. FDA has granted Breakthrough Device Designation to SPINEstat® (14-3-3eta Autoantibody Multiplex Immunoassay Test), recognizing its potential to address a significant unmet need in the diagnosis of patients with axial spondyloarthrit
(Financial Post, 2025-10-28T11:11:02Z)