Augurex Life Sciences Receives FDA Breakthrough Device Designation for SPINEstat® Diagnostic Test for Axial Spondyloarthritis
Augurex Life Sciences Corp., a developer of autoimmune diagnostic tests, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its SPINEstat® 14-3-3eta Autoantibody Multiplex Immunoassay Test.
The test, already approved in Canada and the United Kingdom, is designed to assist in diagnosing axial spondyloarthritis (axSpA).
AxSpA is a chronic autoimmune disease that causes inflammation and pain in the spine, usually in adults under 45 years old.
Many patients face diagnostic delays of seven to ten years, as symptoms are often mistaken for mechanical back pain, leading to delayed treatment and irreversible spinal damage.
SPINEstat® measures autoantibodies to the 14-3-3eta protein using a multiplex immunoassay. Data presented at the American College of Rheumatology (ACR) Convergence meeting showed the test to be highly specific and sensitive in distinguishing axSpA from mechanical back pain.
By complementing existing clinical tools and assessments, SPINEstat® aims to improve diagnostic accuracy and reduce delays in specialist referral.
The FDA designation supports Augurex’s plan to advance SPINEstat® through regulatory review in the U.S. while expanding its availability under Laboratory Developed Test pathways and continuing global commercial launches.
