Vancouver, BC – August 22, 2024 – Augurex Life Sciences Corp., a leader in biomarker-driven diagnostic solutions for the detection and management of autoimmune diseases, today announced its successful certification under the Medical Device Single Audit Program (MDSAP). This milestone reinforces Augurex’s commitment to the highest quality and regulatory standards in North America and across global markets.
MDSAP certification, overseen by International Medical Device Regulators Forum member countries (US, Canada, Australia, Brazil, Japan), as well as the official Observer and Affiliate countries around the world, allows for a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple jurisdictions. This comprehensive certification enables Augurex to streamline its regulatory processes and expand the global reach of its proprietary 14-3-3η biomarker and auto-antibody platforms for the diagnosis and management of autoimmune diseases, such as rheumatoid arthritis and axial spondyloarthritis.
“Achieving MDSAP certification is a significant accomplishment that reflects our dedication to maintaining the highest level of quality in every aspect of our operations,” said Neil Klompas, CEO of Augurex. “This certification enables us to accelerate our international growth while ensuring that our products continue to meet rigorous global regulatory and quality standards. Moreover, MDSAP certification plays a key role in our commitment to creating access to our diagnostics for patients and their physicians around the world.”
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 14-3-3η protein, available as JOINTstat® in Canada, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis. The analyte specific reagents to detect 14-3-3η are available for purchase and use by U.S. clinical laboratories as a component of diagnostic tests developed by such laboratories. SPINEstat® expands Augurex’s biomarker-informed diagnostic autoimmune portfolio 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.
Media Contact
Nima Mazinani
604-674-8231