Skip to main content
Premium Trial:

Request an Annual Quote

Australian Diagnostic Firm Minomic Steps Into US With Prostate Cancer Test Launch


NEW YORK – With its risk stratification blood test for prostate cancer in hand, Australian diagnostic company Minomic is targeting the US market in its ongoing commercial efforts.

The MiCheck Prostate test, which the company has been developing since 2016, uses three blood protein markers, as well as clinical factors, to determine which patients may be at risk of aggressive prostate cancer and need follow-up care after receiving an elevated prostate-specific antigen (PSA) test result. The aim of the test, said Minomic CEO Brad Walsh, is to help physicians determine which patients should move further down the care pathway and receive a tissue biopsy.

"The place we want to differentiate between is not so much those that have cancer as those that have aggressive cancer, [but] those that we need to do something about right away," he said.

MiCheck Prostate relies on a combination of protein markers detected with a clinical chemistry analyzer, such as one from Roche or Abbott, and clinical factors that are fed into a proprietary algorithm that determines a percent risk. That risk correlates to a category of low risk or increased risk that is presented to the physician in a colored chart, or "temperature bar," Walsh said — anything above 5 percent goes into the increased risk bucket.

Minomic currently has a US subsidiary with a CLIA laboratory in Gaithersburg, Maryland, that runs the test and has multiple patents for its prostate cancer technology, Walsh said. The test combines the measurements of three protein biomarkers, along with clinical factors, to determine its results. Walsh declined to specify exactly which biomarkers the test uses because data on the commercial version of the test hasn't yet been published, although a paper is currently being drafted.

Walsh noted that the test "is not a diagnosis in itself," but rather a decision tool to help clinicians determine the need for a biopsy and "getting as much information as you can in that workup" for the patients.

The company is just now starting to commercialize the test in the US — blood collection kits have gone out to multiple urology practices across the country, and so far, about 60 non-commercial samples from four practices have been analyzed, Walsh said, with commercial samples beginning soon. The firm is quoting a weeklong turnaround time for customers to account for shipping and potential delays, but the test itself can be performed in about a day, he said.

Currently the assay is being offered as a laboratory-developed test, but he said that as time goes on the firm will "look at how that demand builds" and determine if it will seek clearance from the US Food and Drug Administration to sell the kit commercially. Minomic has also already sought reimbursement and will crosswalk the test to an established CPT code with a $760 reimbursement price, he said.

In its home country of Australia, the company has partnered with Sonic Healthcare and is "two to three weeks" away from launching the assay, he said. Minomic is also looking outside of the US and Australia, likely to the UK next with CE-marked countries to follow, Walsh said.

The prostate cancer testing market is well-saturated — Opko Health offers its 4KScore test, MDxHealth recently acquired the Oncotype Genomic Prostate Score assay, and Bio-Techne has its ExoDx Prostate IntelliScore test, to name a few — but Walsh said Minomic sees space within the market for the MiCheck Prostate assay. The 4Kscore test from Opko is "closest" to what Minomic offers, but Walsh said MiCheck Prostate has higher specificity, reducing false positives.

An abstract presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium found that the test had sensitivity of 95 percent and specificity of 47 percent in 318 samples. Further unpublished work since the abstract was presented has shown the test with a specificity of 60 percent, Walsh said via email.

Meantime, a 2018 study published in Prostate Cancer and Prostatic Diseases found the 4Kscore had sensitivity of 89 percent and specificity of 29 percent.

However, Minomic isn't necessarily looking to take market share away from Opko or any of the other companies offering prostate cancer tests. It's "quite a large market," Walsh said, and the firm is instead hoping to reach men who aren't using any test at all. "We see space in the marketplace … in terms of people who are not using any test; they're still just relying on PSA and biopsy, so we see the opportunity there."

The company is in the process of raising capital to build up its sales and marketing teams so it can make its way into the market, Walsh said. To date the firm has raised A$28 million (US$17.94 million) and has another A$12 million research and development tax incentive from the Australian government, but Minomic is beginning a funding round to raise an additional US$10 million in equity investment. About two-thirds of that funding will go to building out the US commercial efforts, with most of the rest going toward further commercialization and corporate costs in Australia, he said. However, some of the money is earmarked for conducting a bridging study of the test in China and for helping with the CE marking process.

Minomic also intends to go public on the Australian Securities Exchange in the next year as it builds up its revenues, Walsh said.

Although the company has gone all in on prostate cancer for now, Walsh also hinted that there is some pipeline development in the pancreatic cancer and bladder cancer spaces, with additional patents in the works. "We don't want to be a one-trick pony," he said.