Augurex’s Spinestat diagnostic test earned the FDA’s breakthrough device designation.
Spinestate is a 14-3-3eta autoantibody multiplex immunoassay test for diagnosing axial spondyloarthritis, according to an Oct. 28 news release. It’s designed to address an unmet need in the early and accurate differentiation of axSpA in patients with chronic back pain.
With breakthrough designation, Augurex will get additional collaboration and support from the FDA during the regulatory approval process.
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