Health Canada has approved SPINEstat, a diagnostic blood test developed by Augurex Life Sciences, for use in detecting axial spondyloarthritis (axSpA).
The regulatory classification confirms SPINEstat as a Class II medical device, enabling its clinical use across Canada.
SPINEstat identifies auto-antibodies to the 14-3-3eta protein, offering clinicians a validated and objective biomarker to support the diagnosis of axSpA. This development addresses a long-standing challenge in autoimmune disease detection, where clinical ambiguity and overlapping symptoms with common back conditions often result in delayed diagnosis.
Axial spondyloarthritis is a chronic inflammatory autoimmune condition impacting an estimated 400,000 people in Canada. The disease typically emerges before the age of 45 and frequently manifests as persistent back pain.
Due to the non-specific nature of early symptoms, diagnosis is often delayed by seven to ten years after initial onset, during which time disease progression may continue undetected.
Augurex stated that SPINEstat is designed to assist healthcare providers in distinguishing axSpA from other causes of chronic back pain, a symptom affecting approximately 30% of adults in North America.
By incorporating biomarker testing into the diagnostic pathway, the company aims to support earlier clinical intervention.
Augurex CEO Neil Klompas said: “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 approval of SPINEstat represents a continuation of Augurex’s focus on autoimmune biomarker development and regulatory expansion.
The company said that the diagnostic is expected to provide a new testing tool for clinicians managing patients with non-specific or prolonged back pain, which is often misattributed to mechanical causes or general wear-and-tear.
This regulatory milestone follows another development by the company last month. Augurex announced that its diagnostic blood test JOINTstat, also based on the 14-3-3eta protein, received UK Conformity Assessed (UKCA) marking.
JOINTstat was also registered as an in vitro diagnostic device with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
