Proteomics’ PromarkerD test for DKD has been launched in Australia, and two more tests will launch later in 2025

2025 has been, and will continue to be, a big year for Proteomics, which has just launched PromarkerD onto the Australian market. Before this year is over, the company anticipates launching another 2 tests – PromarkerEndo and PromarkerEso; and is eyeing off the US market too.

Recap of Proteomics (ASX:PIQ)

For investors that are new to the Proteomics story, we think it is worth recapping the progress it has made. Proteomics has 3 tests:

• PromarkerD for DKD,
• PromarkerEndo for Endometriosis and,
• PromarkerEso for Esophageal cancer.

These are all named after PIQ’s Proteomics platform that can create diagnostic tests based on the differences in the protein make-up of people with and without a disease. PromarkerD is a predictive test (meaning it can predict the likelihood of developing Diabetic Kidney Disease) while PromarkerEndo and PromarkerEso are purely diagnostic tests.

The benefit of these tests is that they can help diagnose conditions earlier than conventional methods can now and can allow for earlier intervention that may be more effective. What’s more is that many methods today are highly invasive, for instance endometriosis can only be diagnosed with invasive surgery, or they may not be accurate or sensitive unless the disease is at a later stage. Several studies over the years have validated Proteomics’ tests and their ability.

PromarkerD is live in Australia

PromarkerD was launched in Australia in mid-March 2025. It was first rolled out in Western Australia through healthcare professionals prior to its release nationwide. The company will engage with key stakeholders across primary care networks, diabetes clinics and professional bodies to support widespread adoption of PromarkerD across Australia. The company will collaborate with health insurers, patient advocacy groups, and government bodies to explore potential reimbursement pathways, to make the test accessible to all Australians living with diabetes.

PromarkerD is expected to be launched in the US in the coming months. Although formal FDA approval (i.e. 510(k) approval) has not yet been granted, the company is able to provide the test in the US via the Lab Developed Test (LDT) pathway and will be using this method. To this end, the company has opened its own CLIA-certified laboratory in California that will be able to provide the test prior to FDA approval. Europe is also a target market for PromarkerD, and the test is CE Mark registered in the EU, but this will come after the Australian and US launches.

There is a significant market for the test. It is estimated that 1 in 3 diabetics have DKD, 90% of whom have Type 2 diabetes. This would equate to 10.66m patients in the USA, 20.66m in the EU, and 500k people in Australia based on estimates outlined in further detail in our initiation report. But PIQ believes it can instead serve those who don’t have DKD, predicting whether or not they will develop DKD.

PromarkerEndo and PromarkerEso to come later this year

Proteomics will launch PromarkerEndo and PromarkerEso in Australia before 2025 is out, with the USA and the EU thereafter. In the case of all its tests, Proteomics will not pursue a licensing model as many ASX biotechs are right now, but a Direct to Consumer/Patient (DTC/DTP) model.

This may mean Promarker may not reach as high a proportion of the market – at least not as fast – as it would have with a licensing deal, but it will mean the company keeps a higher share of revenue than it otherwise would. PIQ’s strategy has been to build awareness among Key Opinion Leaders and primary care physicians over the last several years.

Some investors may be concerned about what the Trump administration means for PIQ, particularly the threat of tariffs and the possibility that FDA job cuts will slow things down. We think the company’s US Reference Laboratory will reduce the risk of tariffs and the company’s CLIA path should mean a slowing down of FDA regulatory approval processes may not impact the company in the short-term.

In the longer-run, we see the possibility that potential FDA reforms (one floated idea being a split of the FDA into two agencies, one focused on food and the other on medical products) or cutting of red tape could benefit the company’s regulatory approval case.

Ultimately, the fact that PIQ was able to raise $4.5m in the month of April 2025 is a testament to investors’ confidence in the company, no matter what the situation is with the FDA and tariffs. Our friends at Pitt Street Research have just published an update note on Proteomics and it values the company at $2.34-3.47 per share.

Conclusion

Not many companies can claim to be releasing 3 diagnostic tests in a year, but Proteomics (ASX:PIQ) is one of them. Investors have an exciting time ahead of them.

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