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Highlights

  • PIQ introduces PromarkerD in the US, targeting early-stage diabetic kidney disease detection.
  • The company begins rollout via CLIA-certified lab and digital engagement platform.
  • PIQ leverages ADA’s global diabetes forum to engage clinicians and showcase clinical results

Proteomics International Laboratories Ltd (ASX:PIQ) is a medical technology company specialising in precision diagnostics and bio-analytical services. It operates under the trading name Proteomics International and is a wholly owned subsidiary of PILL.

The company has announced the official US launch of its PromarkerD test for diabetic kidney disease, unveiled at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago. PromarkerD is designed to identify the risk of developing diabetes-related chronic kidney disease (DKD) up to four years in advance in individuals with type 2 diabetes.

The US launch of the test represents a significant milestone in Proteomics International’s global expansion strategy. The test has been validated in multiple large-scale clinical studies and aims to provide healthcare professionals with a predictive tool that enables earlier interventions to slow or prevent kidney function decline.

PromarkerD was introduced at the ADA conference, the world’s largest gathering of diabetes professionals, providing Proteomics International with the opportunity to engage directly with clinicians, researchers, patient advocacy groups, and commercial partners. As part of the launch, the company also presented new clinical data as part of a Late Breaking Abstract session titled “Next-Generation PromarkerD vs Standard of Care for Assessing Kidney Function Decline in Type 2 Diabetes.”

The PromarkerD test is currently being offered in California through Proteomics International’s recently established CLIA-certified Reference Laboratory located in Irvine. The test will be made available to both patients and primary care physicians via a hybrid commercialisation strategy that includes direct-to-consumer outreach and healthcare partner channels.

Proteomics International is also engaging with potential licensees and distributors, as well as insurance providers, as part of its efforts to scale adoption of PromarkerD across the US. The company first launched the test in Australia on World Kidney Day, where a pilot rollout in Western Australia and the Northern Territory helped refine logistics and the digital platform that underpins its direct-to-consumer model.

DKD is a major health burden, affecting roughly half of all adults with diabetes. The disease is frequently asymptomatic in early stages, making early detection crucial. According to the American Society of Nephrology, untreated chronic kidney disease can lead to irreversible damage, requiring dialysis or a kidney transplant. The cost of DKD to the US healthcare system is estimated at approximately USD 130 billion annually, representing a quarter of the total Medicare budget. Without early intervention, the number of US kidney failure patients is expected to exceed one million by 2030.