The US Food and Drug Administration (FDA) has granted breakthrough device designation to Augurex Life Sciences鈥� SPINEstat 14-3-3eta Autoantibody Multiplex Immunoassay Test for axial spondyloarthritis (axSpA) diagnosis.
Already approved in the UK and Canada, the test is designed to diagnose this autoimmune condition, causing persistent back pain, primarily in the adult population under the age of 45 years.
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The disease is said to be often mistaken for common low back pain, leading to misdiagnosis. Without proper treatment, axSpA can result in decreased spinal mobility and even fusion of the vertebrae.
SPINEstat operates by measuring autoantibodies to the 14-3-3eta protein.
According to Augurex, recent data showcased at the American College of Rheumatology (ACR) Convergence conference highlighted the test’s high specificity as well as sensitivity in distinguishing axSpA from mechanical back pain.
The test is said to complement current diagnostic methods, incorporating symptoms, clinical findings, and signs, to aid in clinical decision-making for rheumatology specialists.
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By GlobalDataAugurex plans to collaborate with the US regulator to expedite the regulatory review process for the test.
Concurrently, the company is working on widening the test’s availability as analyte specific reagents (ASRs) and general-purpose reagents (GPRs) under the laboratory-developed test in the US.
This is in line with broader commercial launches planned for the UK, Canada, and other international markets.
Augurex Life Sciences CEO Neil Klompas said: 鈥淩eceiving FDA breakthrough designation for SPINEstat marks a major milestone for Augurex and an important step forward for patients living with inflammatory back pain.
鈥淭his recognition from the FDA underscores the potential of SPINEstat to close a long-standing diagnostic gap for this debilitating condition by providing patients and physicians with a new objective and specific tool to differentiate axSpA from mechanical back pain and access the appropriate medical care.鈥�
