How Proteomics International is Revolutionizing Disease Detection with New Blood Tests

• ISO 15189 certification granted for Australian diagnostic laboratory
• National launches of PromarkerD (diabetic kidney disease) and PromarkerEso (esophageal cancer)
• CPT PLA billing code awarded for PromarkerD in the US, enabling reimbursement
• Founder and Managing Director Dr Richard Lipscombe to retire in February 2026
• Cash receipts of AUD 1.86 million and $10 million cash reserves with $6 million funding boost

Precision Diagnostics Milestone, ISO Certification and Test Launches

Proteomics International Laboratories Ltd (ASX, PIQ), a pioneer in precision diagnostics, has marked significant progress in its commercialisation journey during the September 2025 quarter. The company’s Australian laboratory operations achieved ISO 15189 medical testing certification, a globally recognised standard that underscores the quality and reliability of its diagnostic services. This certification is a critical enabler for the rollout of its proprietary tests, including the recently launched PromarkerD and PromarkerEso.

PromarkerD, designed to predict diabetic kidney disease (DKD) up to four years before symptoms emerge, was launched nationally in Australia in August and is now accessible through over 2,100 blood collection sites and via GP referrals. The test’s next-generation system aligns with routine pathology workflows and has demonstrated strong performance metrics, published in a respected clinical journal. In parallel, PromarkerEso, a blood test for early detection of esophageal adenocarcinoma, was launched in September, leveraging the same logistical framework and digital platforms as PromarkerD.

US Market Progress and Reimbursement Advances

In the United States, Proteomics International has secured a dedicated CPT PLA billing code for PromarkerD from the American Medical Association, a pivotal step that facilitates reimbursement and wider adoption. The test is currently available via direct-to-consumer channels and primary care physician referrals, with initial sales recorded. Blood collection sites have been established in key Californian counties, with plans to expand. The company anticipates that sales volumes will grow as clinicians become more familiar with the test and formal reimbursement pricing takes effect in January 2026.

Proteomics International is also advancing discussions to extend its PromarkerD licensing in Latin America and Europe, while refining its go-to-market strategies to build awareness among clinicians, key opinion leaders, and patient advocacy groups.

Pipeline Development and Strategic Partnerships

Beyond PromarkerD and PromarkerEso, the company is progressing PromarkerEndo, a diagnostic test for endometriosis, with commercial launch targeted for the second half of 2025 in Australia. Collaborations with leading medical institutions have been expanded to support clinical validation and future test development. Additionally, the OxiDx test, which monitors oxidative stress and muscle recovery in athletes and racehorses, has demonstrated promising results in peer-reviewed studies and is poised for commercial launch.

Leadership Transition and Financial Position

Proteomics International announced that its founder and Managing Director, Dr Richard Lipscombe, will retire in February 2026 after 25 years at the helm. A specialist executive search firm has been engaged to identify a successor with global expertise in diagnostics and digital health. The company also appointed David Wood as Joint Company Secretary and welcomed Vicki Robinson to its board, bringing extensive executive and governance experience.

Financially, the company reported cash receipts from customers of AUD 1.864 million for the quarter, including a significant non-recurring receipt linked to its collaborative proteomics facility. Operating cash outflow was AUD 0.8 million, with cash reserves standing at AUD 10 million. A $6 million funding boost for the WA Proteomics Facility will support further expansion of precision diagnostics capabilities.

Outlook

Proteomics International is well positioned to capitalise on the growing demand for decentralised, precision diagnostic tests driven by telehealth and preventative care trends. The company’s multi-pronged commercialisation approach, combining direct-to-consumer access with strategic partnerships and licensing, aims to build market recognition and revenue streams globally. The upcoming leadership transition and ongoing reimbursement developments will be key factors to watch as the company scales its innovative diagnostic solutions.

Bottom Line?

With ISO certification and multiple test launches behind it, Proteomics International’s next challenge lies in scaling adoption and navigating leadership change.

Questions in the middle?

• How quickly will PromarkerD and PromarkerEso gain traction among clinicians and patients in Australia and the US?
• What impact will the appointment of a new CEO have on the company’s strategic direction and partnerships?
• When will formal reimbursement pricing for PromarkerD be set by US payers, and how will it affect sales volumes?