• Cleo Diagnostics is developing blood test for accurate and early detection of ovarian cancer
  • Test follows 10 years of medical research with planned three phase path to market
  • Cleo Diagnostics is making ASX debut after raising $12 million at 20 cents per share


Making its debut on the ASX today is Cleo Diagnostics, which is working to reduce the fatality rate of ovarian cancer via a simple blood test.

Ovarian cancer is a nasty disease, with non-specific symptoms which can be mistaken for other less lethal illnesses making it hard to diagnose.

Consequently, cases go undetected until later stages when prognosis is poor, Cleo Diagnostics (ASX:COV) CEO Richard Allman says.

“The average five-year survival is 49% which is heavily skewed by those women who have their disease caught early,” he says.

“The reality is that perhaps three quarters of cases are detected at late stage. Their five-year survival is quite dismal, with only 17% of stage four cases surviving more than five years.”

Early detection for ovarian cancer is critical at boosting survival rates. Allman says if the cancer can be detected early while still confined to the ovary, five-year survival is up ~90%.

In other female cancers such as cervical and breast, where early detection testing is available, survivability rates are now at 74% and 92% respectively.

Early detection is the name of the game for COV, which is making its debut on the ASX after raising $12 million at 20 cents per share.

There is no accurate, pre-surgical method to diagnose ovarian cancer, or to differentiate between malignant or non-cancerous (benign) disease.

The only blood test available is one for a tumour biomarker called CA125 and unfortunately it does not work very well.

“It is only expressed by about half of women with ovarian cancer so it’s no good as a screening test,” Allman says.

“There have been several large-scale trials in the past with the most recent in the UK and showing no improvement in survival by offering that test as a screening test for women.”

“COV will be making an application to access that same trial data to validate CLEO’s test to shorten R&D time to bring the product to market, but we are very hopeful our test will show good results in that screening population.”


Backed by 10 years of science

Allman says COV’s cancer diagnostics technology platform is underpinned by a patented novel biomarker, CXCL10, which is produced early and at high levels by ovarian cancers, but not in non-malignant disease.

The platform is backed by over 10 years of scientific R&D at the Hudson Institute of Medical Research in Melbourne with funding supported by the Ovarian Cancer Research Foundation, with two clinical studies conducted with over 500 patients.

Pursuant to a licence agreement with the Hudson Institute of Medical Research, COV has a worldwide exclusive licence to commercialise the intellectual property which underpins its operations and the ovarian cancer tests.

COV’s chief scientific officer and executive director Dr Andrew Stephens leads an independent academic research group at Hudson investigating mechanisms that contribute to the formation, progression and dissemination of high grade, serous epithelial ovarian cancers.

Since 2010, his research has focused on biomarker identification and development in ovarian cancer, and the development of therapeutic strategies to improve patient outcomes.

“Andrew’s team has showed that biomarker is expressed in pre-malignant lesions, something called a P53 lesion, which occur between 10 and 18 months prior to a visible tumour,” Allman says.

“That characteristic means it’s extremely useful as a potential diagnostic marker for early detection.”

Stephens’ work came to the attention of Allman and his colleagues. Allman has more than 30 years of scientific research leadership and innovation with a clear focus on commercialisation.

“We did a lot of due diligence around the science to see if it stood up, examined the market need and whether the technology passed scrutiny,” he says.

Allman says the blood test they are developing is not a stand-alone single biomarker test but will be combined in a panel with several other biomarkers.

“The reason being we are trying to increase the sensitivity and specificity of the test as much as possible,” he says.

“By combining the biomarker with a panel of others the early indications are we have extremely high sensitivity and specificity for Cleo’s test.”


Three phase product development strategy

Allman says bringing any diagnostic product to market is difficult. He says COV was conscious of ensuring that there was a clear path to commercialisation.

“The way we’ve solved this problem is through a three-phase product development strategy,” he says.

“We’ll essentially be bringing to market three different applications with the same underlying technology.”

He says the equivalent of Phase one trials has already been done by the Hudson team.

“We are at a later stage in product development and are hoping to piggyback on larger clinical trials to reduce development time,” he says.


Phase 1 – Pre-surgical triage test

Allman says the first to come to market will be a pre-surgical triage test, designed to discriminate between benign and malignant disease from symptomatic women.

“The vast majority will be benign ovarian cysts but unfortunately a small percentage will be ovarian cancer,” he says.

“The reason such a product is important is that those two groups of women require very different management strategies for the best outcomes.”

Currently, surgery and ensuing diagnostic pathology on the removed ovaries is the only way to definitively diagnose an ovarian tumour.

“If you haven’t got ovarian cancer, you can’t simply put the ovaries back again so having a test to accurately discriminate between benign and malignant before surgery is clinically important,” Allman says.

He says there are similar pre-surgical triage test products available in the US, but they don’t perform particularly well.

“For us commercially it means we have a simple route to market and intend to make a US FDA application for this triage test in approximately two years,” he says.

“It’s not an R&D program but a simple benchmarking exercise and a small clinical study to see how Cleo’s test performs against those existing tests and we’re confident it’s better.”

Allman says the pre-surgical triage test has a straightforward commercialisation route, which is why it is the first phase of their product development strategy.

“The reason for bringing the test to market in a three-phase approach is that different applications have various levels of complexity in clinical trial support,” he says.

“The triage test for presurgical between benign and malignant is the smallest clinical trial for us.”


Phase 2 – Disease recurrence test

Allman says the disease recurrence test is designed to detect early relapse for patients previously diagnosed with ovarian cancer.

“Its for patients who’ve had their surgery and chemo, but the unfortunate reality is the vast majority of those patients will relapse at some stage,” he says.

“The vast majority of patients will relapse and most within 18 months so if we can detect that recurrence earlier it’s not so much about extending life but giving more treatment options to improve quality of life.”


Phase 3 – Screening test for wider community adoption

In the longer term COV is looking to bring the technology to market as a screening test, but this will involve a much larger clinical study and take longer to deliver.

“The intention is offering that test to all women of screening age,” Allman says.

He says if you can detect ovarian cancer early, perhaps as part of regular screening when women have mammograms for breast cancer detection, then there are significant advantages.


Need for ovarian cancer detection

Allman says in key markets of the US, Europe, and Australia around 300,000 new cases are diagnosed annually.

“While it may not sound that many the vast majority are detected quite late and the majority will die. The clinical need for a good diagnostic is huge,” he says.

It is estimated that by 2040, the number of women around the world diagnosed with ovarian cancer will rise almost 42%.

An accurate and early detection blood test could shift survivability for ovarian cancer significantly as seen with other cancers.


This article was developed in collaboration with Cleo Diagnostics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.