Proteomics International Achieves ISO 15189 Certification – A Core Milestone in Precision Diagnostics
- Noel Ong
- Oct 3
- 5 min read
Announcement
Proteomics International Laboratories Ltd (ASX: PIQ) has been granted ISO 15189 certification for its Australian laboratory operations – a key milestone that cements its role as a leader in precision diagnostics. This certification validates the company’s systems, processes, and quality management, ensuring accurate and dependable clinical results.
This certification is more than a tick-the-box moment — it is the green light for the national roll-out of PromarkerD and PromarkerEso. Building on PIQ’s status as one of the world’s most accredited protein testing laboratories — with ISO 15189, ISO 17025, and ISO 13485 certifications — it delivers the quality and clinical confidence needed to drive adoption and future partnerships (Figure 1). This announcement marks a major step forward in PIQ’s commercialisation journey.
Figure 1: Certification & Credibility (source: PIQ)
Key Highlights - The Business of Precision Diagnostics.
ISO 15189 Certification Granted – covering clinical testing services, supporting the commercialisation and clinical use of Proteomics International’s suite of precision diagnostic tests.
Strengthens Global Standing – affirms Proteomics International’s position as one of the world’s leading laboratories for proteomics and protein-based testing services.
Platform for Growth – enables offering of emerging precision diagnostics and specialist pathology tests.
Aligned with Strategic Roll-Out – builds on ISO 17025, ISO 13485, and CLIA certifications, strengthening the national roll-out of PromarkerD (launched 20 August) and PromarkerEso (launched today) (Figure 2).
Figure 2: PromarkerEso (source: PIQ)
Proteomics International Managing Director Dr Richard Lipscombe commented:
“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. 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.”
Strategic Impact
This milestone is more than just compliance – it opens doors to new revenue streams and positions Proteomics International at the forefront of the precision medicine market. Figure 3: Go-to-Market Optionality illustrates the company’s dual commercialisation pathways — the direct-to-consumer and digital marketing pathway, and the traditional licensing model — both of which are now underpinned by ISO 15189 certification. This assurance gives clinicians, regulators, and payers confidence that PIQ’s diagnostic results are reliable, creating the trust required to accelerate adoption and monetisation.
Figure 3: Go-to-Market Optionality: Synergistic Pathways (source: PIQ)
About Proteomics International
Proteomics International Laboratories (PILL) is a Perth-based medical technology company specialising in proteomics – the large-scale study of proteins (Figure 4).
Figure 4: The power of proteins (source: PIQ)
Its mission is to improve lives through innovative tools that enhance disease detection and treatment (Figure 5).
Figure 5: Predictive Diagnostics (source: PIQ)
IDENTITY: Proteomics International is a medical technology company specialising in predictive diagnostics and advanced analytical services using proteomics - the industrial-scale study of the structure and function of proteins.
MISSION: To improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.
VISION: To help create a world where disease is detected early and cured simply.
The Power of Early Detection
(Figure 6)
Early detection finds disease in its earliest stages, allowing earlier and more effective treatment.
Many diseases go undiagnosed early due to limitations of diagnostic tools and silent symptoms.
Government screening programs (e.g., the National Cervical Screening Program) show how early detection reduces illness and death.
NCSP invites women aged 25–74 for HPV testing every 5 years, preventing up to 95% of cervical cancers.
Since its introduction in 1991, NCSP has halved cervical cancer incidence and placed Australia on track to eliminate cervical cancer by 2035.
Development of innovative diagnostic technology is key to improving early detection across other diseases such as breast cancer, lung cancer, cardiovascular disease, and dementia.
Figure 6: The Power of Early Detection (source: PIQ)
Samso Concluding Comments
This could be a defining moment for Proteomics International (PIQ). The achievement of ISO 15189 certification is not simply an operational milestone — it is the foundation for commercial success. For investors, this means PIQ’s diagnostic tests can be rolled out with confidence, knowing they meet the strictest global standards for clinical accuracy.
The combination of PromarkerD and PromarkerEso, now being offered under certified conditions, means that PIQ has entered a new phase of execution and market adoption. This is when investors start to look for metrics — such as the number of tests conducted, clinics onboarded, and revenue growth — to measure traction.
From a strategic perspective, this certification unlocks PIQ’s ability to partner with other test developers, potentially broadening its revenue mix and cementing its reputation as a precision diagnostic hub.
Has PIQ de-risked the path forward and is now positioned to convert its scientific achievements into sustainable, scalable commercial outcomes?
The Samso Way – Seek the Research
Always look beyond the headline. ISO 15189 is a gateway to market adoption, but the real test will be how rapidly PIQ converts this into clinical uptake and revenue. Watch for quarterly updates on PromarkerD and PromarkerEso adoption and monitor the pipeline for the next test candidates.
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