Augurex Secures Health Canada Approval for SPINEstat™, a First-in-Class Diagnostic Blood Test for Axial Spondyloarthritis

• SPINEstat™, a novel, first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), has been approved by Health Canada. This approval marks an important milestone in addressing a significant global unmet need in axSpA.
• As an inflammatory autoimmune condition impacting the spine, axSpA often goes undiagnosed, mistaken for persistent lower back pain for 7-10 years before an accurate diagnosis. There is an urgent need to decrease the diagnostic delay for axSpA.
• If untreated, axSpA is a highly debilitating disease that causes irreversible spinal fusion leading to reduced mobility and quality of life. It can strike at any age, but typically begins before age 45, during the most productive years of a person’s life.

VANCOUVER, British Columbia--(BUSINESS WIRE)--Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, today announced that Health Canada has approved SPINEstat™, a first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), as a Class II medical device. By detecting auto-antibodies to the 14-3-3eta protein, SPINEstat™ provides an important new clinically validated and objective biomarker to aid in the early and accurate diagnosis of axSpA.

AxSpA is a chronic inflammatory autoimmune disease that affects approximately 400,000 Canadians. It often strikes in the most highly productive years of a person’s life, with symptoms starting before age 45. It presents significant diagnostic challenges, with a typical and well-documented delay of 7-10 years from symptom onset to confirmed diagnosis, often presenting as chronic back pain lasting for years.

Persistent back pain, which affects nearly 30% of North American adults, is often overlooked as a symptom of axSpA. SPINEstat™ offers physicians an important new tool to help differentiate axSpA from other causes of chronic back pain, addressing a critical gap in diagnostic options.

Neil Klompas, CEO of Augurex, highlighted the importance of this milestone, noting that, “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. 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.”

"The diagnostic journey for axial spondyloarthritis remains one of the most significant challenges facing our community, with patients often waiting 7-10 years before receiving an accurate diagnosis,” notes Brenda Delodder, executive director with the Canadian Spondyloarthritis Association. “During this time, Canadians experience unnecessary suffering, progressive damage, and diminished quality of life. At the Canadian Spondyloarthritis Association, we welcome all advances that have the potential to shorten this diagnostic delay, reduce misdiagnosis and help patients access the treatment they need much earlier.”

With this approval, Augurex reinforces its commitment to advancing autoimmune diagnostics, providing healthcare professionals with innovative tools for earlier and more accurate disease detection.

About Augurex

Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex’s lead diagnostic test which detects the 14-3-3eta protein, available as JOINTstat® in Canada and Great Britain, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis. The analyte specific reagents to detect 14-3-3eta are available for purchase and use by U.S. clinical laboratories as a component of diagnostic tests developed by such laboratories. The Anti-14-3-3eta Multiplex ASRs, approved as SPINEstat™ in Canada, expands Augurex’s biomarker-informed diagnostic autoimmune solutions into axial spondyloarthritis, an autoimmune disease often misdiagnosed as low back pain, and which if untreated can lead to impaired spinal mobility and fusion of the vertebrae. Learn more about Augurex at www.augurex.com and follow us on Facebook, LinkedIn and X.