FDA: Breakthrough Nod to SPINEstat’s Axial Spondyloarthritis Tool

Orthopedic surgeons who regularly see patients with “mystery back pain” may soon have a powerful new ally in the diagnostic arsenal.

Augurex Life Sciences Corp. has announced that the FDA has granted Breakthrough Device Designation to its SPINEstat^® 14-3-3eta Autoantibody Multiplex Immunoassay Test — a first-in-class blood test designed to differentiate axial spondyloarthritis from mechanical back pain.