Proteomics International Achieves ISO 15189 Certification, Expanding Clinical Testing Capabilities
Proteomics International Laboratories has achieved ISO 15189 certification for its Australian lab, marking a pivotal step in commercialising its precision diagnostic tests like PromarkerD and PromarkerEso.
- ISO 15189 certification granted for Australian laboratory operations
- Certification supports commercial rollout of PromarkerD and PromarkerEso tests
- Affirms global leadership in proteomics and protein-based testing
- Builds on existing ISO 17025, ISO 13485, and CLIA accreditations
- Positions company for future specialist pathology test offerings
Certification Milestone
Proteomics International Laboratories Ltd (ASX, PIQ) has reached a significant milestone with the granting of ISO 15189 certification for its Australian laboratory operations. This accreditation, awarded by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA), is a globally recognised standard specifically designed for medical laboratories. It ensures the highest quality management and technical requirements are met, guaranteeing accurate and reliable clinical test results.
Commercial Implications
The certification is a critical enabler for the company’s commercial ambitions, underpinning the national rollout of its precision diagnostic tests, including the recently launched PromarkerD for diabetic kidney disease and PromarkerEso for esophageal cancer. These tests represent the forefront of precision medicine, offering tailored diagnostic insights that could transform patient outcomes.
Building on a Strong Foundation
This latest certification complements Proteomics International’s existing accreditations, ISO 17025, ISO 13485, and CLIA, further cementing its reputation as a world leader in proteomics and protein-based testing services. The company’s Managing Director, Dr Richard Lipscombe, highlighted that ISO 15189 certification not only validates current operations but also provides a platform to expand into emerging specialist pathology tests, potentially unlocking new revenue streams as precision medicine gains traction.
Strategic Outlook
Proteomics International’s pipeline includes multiple precision diagnostic assets targeting significant public health challenges. The company’s commitment to quality and clinical validity, now formally recognised through ISO 15189, positions it well to capitalise on the growing demand for innovative diagnostic solutions. As healthcare increasingly embraces personalised approaches, Proteomics International’s enhanced capabilities could prove pivotal in shaping future diagnostic landscapes.
Bottom Line?
ISO 15189 certification sets the stage for Proteomics International’s next growth phase in precision diagnostics.
Questions in the middle?
- How quickly will PromarkerD and PromarkerEso gain market adoption following certification?
- What new specialist pathology tests might Proteomics International introduce next?
- How will this certification impact the company’s competitive positioning globally?