Proteomics set for revenue boost after launching two products

Proteomics International is a medical technology company at the forefront of precision diagnostics and bio-analytical services that is making giant strides in early detection of serious diseases.

After going commercial in August and September with two medical diagnostic products, Proteomics International (ASX: PIQ) is now set to see a growing pipeline of revenues.

The September 2025 quarter saw the company make significant progress in commercialisation, clinical certification, and pipeline development, supported by a robust financial position.

The company achieved a major milestone when it gained ISO 15189 certification for its Australian laboratory, enabling high-quality clinical testing for its diagnostic suite. This underpins the national rollout of PromarkerD in August, a test predicting diabetic kidney disease (DKD) up to four years in advance.

The international standard specifies the requirements for quality and competence of medical laboratories.

Available via telehealth and over 2100 Healius Pathology collection sites, PromarkerD integrates with GP software, with first sales now recorded.

In the US, 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.

The Current Procedural Terminology (CPT) Proprietary Laboratory Analysis (PLA) code is a unique identifier assigned by the American Medical Association (AMA) to specific laboratory tests, particularly for advanced diagnostic or molecular tests, performed by a single laboratory.

A next-generation PromarkerD test for diabetes that aligns with routine pathology workflows was published in the Journal of Applied Laboratory Medicine, showing 86% accuracy in identifying DKD risk.

Diabetic Kidney Disease (DKD) is a major complication of diabetes, affecting over 537 million people globally, where high blood sugar damages kidneys, leading to reduced function and potential kidney failure.

PromarkerD’s role lies in the identification of protein biomarkers in a blood sample to detect DKD risk – doing so with 86% accuracy, outperforming standard tests like estimated glomerular filtration rate (eGFR) and albumin-to-creatinine ratio (ACR), which aren’t predictive.

PromarkerEso, a blood test for early detection of esophageal cancer was launched in Australia on 18 September at the ISDE World Congress.

New results, published in Diseases of the Esophagus, have confirmed high diagnostic accuracy across all EAC stages, addressing a critical need given the disease’s low 20% five-year survival rate.

The test leverages the same logistics as PromarkerD, with US preparations underway via Proteomics’ CLIA-certified lab in Irvine.

CLIA certification ensures that laboratories performing diagnostic testing on human samples meet stringent quality, accuracy, and reliability standards for clinical testing.

PromarkerEndo, which targets endometriosis diagnosis, is on track for a second half 2025 Australian launch and should add further to Proteomics now developing sales pipeline.

An expanded collaboration with the University of Melbourne and Royal Women’s Hospital will advance clinical validation and develop a tissue-specific test, addressing a condition that affects one in nine women and incurs a massive annual cost of $9.7 billion.

OxiDx, 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. Analytical services, including pharmacokinetic and biomarker analysis, continue to generate steady revenue.

Proteomics customer receipts for the quarter were $1.86m, of which $1.71 million was a non-recurring payment from a WA Proteomics Facility partnership with UWA.

With commercialisation now under way, Proteomics founder and Managing Director Dr. Richard Lipscombe has announced his impending retirement in February 2026 and a global search for a new CEO underway.

With strong cash reserves, strategic partnerships and a pipeline of product either just in the market or coming to market soon, Proteomics looks set for a new journey now that should be punctuated by cashflows.

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