PromarkerD Gains US Billing Code as WA Facility Secures $6M Boost – A Dual Leap for Proteomics International (ASX: PIQ) - The Business of Predictive and Diagnostic Blood Test.
- Noel Ong
- Jul 28
- 7 min read
Updated: Jul 30
Announcement
Proteomics International Laboratories Limited (ASX: PIQ), has taken two strategic steps forward in the span of days, cementing its position as a leader in precision diagnostics. First, the Company secured a $6 million funding package to expand the WA Proteomics Facility in Perth, and now, it has received a dedicated US reimbursement code (CPT PLA 0579U) for its next-generation PromarkerD test. These developments reflect a well-executed plan to build both the physical infrastructure and regulatory framework required to take PIQ’s proteomic technologies into global markets.
Proteomics International Managing Director Dr Richard Lipscombe, commented:
“This facility can become a national hub for precision diagnostic testing across clinical and agricultural proteomics. Extending our recent successful capital raise with state-of-the-art infrastructure to analyse thousands of samples at industrial scale, we can turn biological insight into real-world solutions—whether that’s improving outcomes for patients with chronic diseases or selecting better crop varieties to address food security.”
“Ensuring kidney health is a priority for our company and obtaining this dedicated PLA code is a crucial milestone in our strategy to improve access to meaningful diagnostic tests. Expanding access to PromarkerD will help to improve kidney health for patients everywhere.”
The Business of Proteomics International Laboratories Ltd (ASX: PIQ) - PromarkerD - The Business of Predictive and Diagnostic Blood Test. (source: Proteomics)
PromarkerD is a predictive and diagnostic blood test designed for individuals with type 2 diabetes (and promisingly type 1) to assess the risk of developing diabetic kidney disease (DKD) up to four years before symptoms emerge.
Developed by Proteomics International (Australia), it combines protein biomarkers with clinical data through a proprietary cloud-based algorithm that classifies patients into low, moderate, or high risk categories. Clinical studies demonstrate strong predictive performance—correctly identifying around 86% of at-risk patients—and published research highlights its superiority over traditional kidney-function assays.
The test aims to support early intervention strategies, allowing personalized treatment plans that slow disease progression and improve long-term outcomes.
Commercially, PromarkerD has rapidly expanded since its clinical validation. In March 2025, Proteomics International launched the test in Australia—starting in Western Australia and the Northern Territory—priced around AUD 245, with plans for a nationwide rollout via healthcare providers and a direct-to-consumer model.
Simultaneously, a CLIA-certified reference laboratory in California was opened to enable U.S. commercialization, with promotional support through partners such as Sonic Healthcare USA and Growth Medics in Europe.
PromarkerD sits within a broader precision-diagnostics strategy from Proteomics International, which includes future offerings like PromarkerEso and PromarkerEndo.
Key Highlights – Double Milestone for PIQ
1. $6 Million Co-Investment in WA Facility: A collaborative three-year funding deal involving UWA, PIQ, the WA Government, and Bioplatforms Australia, backed by the NCRIS initiative. PIQ’s own contribution totals $1 million.
2. US AMA CPT Code 0579U Assigned: The American Medical Association has issued a unique PLA billing code for PIQ’s immunoassay-based PromarkerD test, enabling it to be ordered, billed, and tracked under US insurance systems from 1 October 2025.
3. Pricing Submission Made to CMS: PIQ has submitted its recommended pricing to the Centers for Medicare & Medicaid Services (CMS), with preliminary pricing due in September 2025.
4. Industrial-Scale Diagnostic Expansion: The upgraded WA Proteomics Facility will increase throughput and accuracy for biomarker analysis, supporting large-scale diagnostics across both health and agriculture sectors.
5. Strong Pipeline Support: This infrastructure directly supports PIQ’s broader diagnostic pipeline—PromarkerEndo (endometriosis), PromarkerEso (esophageal cancer), and OxiDx (oxidative stress)—in addition to PromarkerD (Figure 1).
Figure 1: The Promarker® suite of diagnostic tests (source: PIQ)
The CPT PLA code is a major milestone in PIQ’s US commercialisation strategy. It unlocks a reimbursement pathway, allowing healthcare providers to order the PromarkerD test, payers to process claims, and regulators to monitor usage. With diabetes-related kidney disease affecting millions globally, and 1 in 3 US adults with diabetes at risk of progression to kidney failure, the test’s potential clinical utility is significant. PromarkerD offers early identification—up to four years before symptoms—allowing for targeted prevention and potentially saving billions in downstream healthcare costs.
On the infrastructure front, the WA Proteomics Facility expansion positions Perth as a national hub for accredited proteomic diagnostics. The facility—operated in partnership with The University of Western Australia—will be upgraded with automated sample handling systems, new diagnostic workflows, and advanced bioinformatics capability. This enables not just PromarkerD, but a suite of PIQ’s diagnostic innovations, to move toward scaled validation and delivery.
What is proteomics?
Proteomics is the large-scale mapping of the structure and function of proteins.
1. Unlike our genes, the protein make-up in our bodies differs from cell to cell and changes considerably over time. For example, a cancerous cell will have significantly different proteins to a healthy cell.
2. The caterpillar and butterfly have exactly the same genes, but differences in their proteins cause dramatic differences during the lifecycle.
Why are proteins important?
While the genome is static throughout life, the proteins expressed by our cells reflect dynamic biological processes, providing a window into the current state of health or disease. The caterpillar and the butterfly have exactly the same genome (Figure 2). The proteins that their cells make are why they are different. By studying protein composition, scientists can develop diagnostics that detect disease earlier, tailor treatments to individuals, and guide agricultural decisions that improve yield and sustainability.
Figure 2: Same genes, different proteins—dramatic change from caterpillar to butterfly. (source: PIQ)
Samso Concluding Comments
With the assignment of a CPT PLA code for PromarkerD in the US and a multi-million-dollar expansion of its WA Proteomics Facility, Proteomics International has pulled off a double play—securing both market access and the infrastructure needed to deliver at scale. These are not speculative moves; they reflect years of focused development, strategic partnerships, and a disciplined approach to commercialisation.
The significance of the AMA code is the gateway to reimbursement, clinical adoption, and commercial traction in the largest diagnostics market in the world. Combined with a test that identifies kidney disease risk years before symptoms emerge, this positions PIQ to deliver meaningful value to patients, payers, and providers. It’s also a strong validation of the Company’s platform and its future potential across multiple diagnostic indications.
Meanwhile, the investment in the WA Proteomics Facility shows a company preparing for real-world application, not just proof-of-concept. It’s a rare moment when infrastructure and regulatory timing align, and PIQ is capitalising on that. For long-term investors, this is the kind of story where today’s groundwork sets the stage for tomorrow’s re-rate.
We often talk about companies that are “ready to scale”—PIQ appear to have both the scientific tools and commercial pathways to do just that. The Business of Predictive and Diagnostic Blood Test is still unfolding, but the pieces are falling into place.
The Samso Way – Seek the Research
These back-to-back announcements reinforce why PIQ is not just a single-product story. The CPT PLA code puts PromarkerD on the reimbursement map in the US—one of the most commercially significant diagnostics markets globally. Meanwhile, the WA facility upgrade provides the technological backbone to support rollout and scale, not just for PromarkerD, but for the Company’s entire diagnostic pipeline. For investors, this is a rare combination: regulatory traction abroad, capacity growth at home, and strong alignment with public and private partners. This is the infrastructure that enables science to become market-ready medicine.
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