First-in-Class Diagnostic Blood Test Detects Axial Spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory autoimmune condition that typically affects individuals during their most productive years, with symptoms often emerging before the age of 45. Diagnosing axSpA is challenging, with a common delay of 7-10 years between the onset of symptoms and a confirmed diagnosis. The disease frequently presents as persistent chronic back pain, which can be easily overlooked as a symptom of axSpA. Without proper treatment, axSpA can lead to debilitating complications, including irreversible spinal fusion that severely impairs mobility and quality of life. Consequently, there is an urgent need to shorten the diagnostic delay for this condition. A newly developed, first-in-class diagnostic blood test for axSpA now offers physicians an objective tool that aids in diagnosis, helping to reduce delays and improve patient outcomes in managing this debilitating disease.

The SPINEstat test, developed by Augurex Life Sciences (Vancouver, Canada), identifies auto-antibodies against the 14-3-3eta protein, providing a clinically validated and objective biomarker for early and accurate axSpA diagnosis. When combined with CRP (C-reactive protein), this test can identify 90% of axSpA cases, thereby enhancing diagnostic accuracy. It is especially valuable for patients who test negative for traditional markers, such as HLA-B27.

Image: Health Canada has approved SPINEstat, a first-in-class diagnostic blood test for axSpA, as a Class II medical device (Photo courtesy of Augurex)

SPINEstat provides healthcare professionals with a crucial tool for distinguishing axSpA from other causes of chronic back pain, filling a significant gap in diagnostic capabilities. By supplementing traditional imaging with this diagnostic support, SPINEstat enables more informed, evidence-based decisions, leading to quicker and more appropriate treatment plans. The test has been approved by Health Canada as a Class II medical device, offering a new and valuable resource in the diagnosis of axSpA.

“Health Canada’s approval of SPINEstat marks a major step forward in axSpA diagnostics, and we are very proud that patients in Canada, and soon around the world, can benefit from this major advancement,” said Neil Klompas, CEO of Augurex. “By providing physicians with an objective tool to aid in diagnosis, Augurex is helping to decrease diagnostic delays and improve patient outcomes in this debilitating disease.”

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Augurex Life Sciences