Proteomics International Laboratories (ASX:PIQ) has achieved a significant milestone in its expansion into precision medicine, securing ISO 15189 certification for its Australian diagnostic laboratory operations.
The accreditation, granted by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA), confirms the company’s compliance with the global standard for medical laboratories. It follows a rigorous audit of facilities, systems, and processes, and ensures that test results meet the highest international benchmarks for quality and reliability.
Managing Director Dr Richard Lipscombe described the certification as a pivotal step in the company’s growth strategy. “The clinical certification supports our strategic growth trajectory as we advance the commercialisation of our first-in-class diagnostic tests for diabetic kidney disease, esophageal cancer and endometriosis,” he said. “This certification also cements Proteomics International's position as a leading innovator in precision diagnostics and provides a platform for us to offer more specialist pathology testing in future.”
The approval builds on the company’s existing ISO 17025, ISO 13485 and CLIA certifications. It paves the way for broader commercialisation of its proprietary Promarker suite of diagnostic tests, including PromarkerD, launched nationally in August, and PromarkerEso, which debuted this month.
By strengthening its laboratory credentials, Proteomics International is positioning itself as a global leader in proteomics and protein-based testing services. The company says the certification will not only underpin the rollout of its in-house developed diagnostics but also support collaborations with emerging third-party precision tests worldwide, opening up new commercial opportunities as precision medicine becomes mainstream.
Founded in Perth, Proteomics International specialises in the large-scale study of proteins to unlock new tools for disease detection and management.