Proteomics International Achieves ISO 15189 Certification, Accelerates Commercial Launch of Precision Diagnostic Tests
核心洞察
Proteomics International secured ISO 15189 certification for its Australian laboratory, enabling high-quality clinical testing and supporting the national rollout of its diagnostic suite.
The company launched PromarkerD (搜索) in August 2025, a blood test that predicts diabetic kidney disease (搜索) up to four years in advance with 86% accuracy, outperforming standard tests.
PromarkerEso (搜索), a blood test for early detection of esophageal cancer (搜索), was launched in September 2025, addressing a critical need given the disease's low 20% five-year survival rate.
Proteomics International Laboratories (搜索) has achieved a critical regulatory milestone with ISO 15189 certification for its Australian diagnostic laboratory operations, positioning the company to accelerate commercialization of its precision medicine diagnostic suite. The certification, granted by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA), confirms compliance with global standards for medical laboratories and follows a rigorous audit of facilities, systems, and processes.
Commercial Launch Momentum Builds
The September 2025 quarter marked significant progress for Proteomics International, with the company achieving major commercialization milestones supported by a robust financial position. The ISO 15189 certification underpins the national rollout of PromarkerD (搜索), launched in August 2025, which represents the company's first major commercial diagnostic product.
PromarkerD (搜索) is a blood test that predicts diabetic kidney disease (搜索) (DKD) up to four years in advance, addressing a critical medical need for the over 537 million people globally affected by diabetes (搜索). The test demonstrates 86% accuracy in identifying DKD risk, significantly outperforming standard tests like estimated glomerular filtration rate (eGFR) and albumin-to-creatinine ratio (ACR), which are not predictive.
Available via telehealth and over 2,100 Healius Pathology (搜索) collection sites, PromarkerD (搜索) integrates with GP software, with first sales now recorded. In the US market, a dedicated CPT PLA billing code (0579U) was granted, effective from October 2025, with reimbursement pricing set for January 2026, supporting its rollout in California.
Expanding Diagnostic Portfolio
PromarkerEso (搜索), a blood test for early detection of esophageal cancer (搜索), was launched in Australia on September 18, 2025, at the ISDE World Congress. New results published in Diseases of the Esophagus confirmed high diagnostic accuracy across all esophageal adenocarcinoma (EAC) stages, addressing a critical need given the disease's low 20% five-year survival rate. The test leverages the same logistics infrastructure as PromarkerD (搜索), with US preparations underway via Proteomics' CLIA-certified laboratory in Irvine.
A next-generation PromarkerD (搜索) test for diabetes (搜索) that aligns with routine pathology workflows was published in the Journal of Applied Laboratory Medicine, demonstrating the company's continued innovation in diagnostic development.
Pipeline Development and Strategic Partnerships
PromarkerEndo (搜索), targeting endometriosis (搜索) diagnosis, is on track for a second half 2025 Australian launch. An expanded collaboration with the University of Melbourne and Royal Women's Hospital (搜索) will advance clinical validation and develop a tissue-specific test, addressing a condition that affects one in nine women and incurs an annual cost of $9.7 billion.
OxiDx (搜索), a test for oxidative stress, has shown promise in a Veterinary Science and Medicine study, tracking muscle recovery in racehorses. With applications in sports and equine industries, OxiDx is also slated for a second half 2025 launch.
Financial Performance and Leadership Transition
Proteomics customer receipts for the quarter were $1.86 million, of which $1.71 million was a non-recurring payment from a WA Proteomics Facility partnership with the University of Western Australia. Analytical services, including pharmacokinetic and biomarker analysis, continue to generate steady revenue.
Managing Director Dr. Richard Lipscombe described the ISO 15189 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 (搜索), esophageal cancer (搜索) and endometriosis (搜索)," 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."
Dr. Lipscombe has announced his impending retirement in February 2026, with a global search for a new CEO underway. The certification builds on the company's existing ISO 17025, ISO 13485 and CLIA certifications, strengthening its position as a global leader in proteomics and protein-based testing services.