Cleo Diagnostics (ASX: COV) - The Ovarian Cancer Blood Test, the Evidence and the FDA Submission

Cleo Diagnostics plans to lodge its ovarian cancer blood test with the United States regulator in the first half of 2027. The trial samples are collected. The test is for women who have an ovarian mass and are booked for surgery. The published accuracy figures are for an earlier version of the test. The company held A$6.2 million in cash at 30 June 2026.

Cleo Diagnostics (ASX: COV) is a Melbourne company with one product in late development. The test gives the doctor a score for how likely an ovarian growth is to be cancer, before the operation. The company calls it the Pre-Surgical Ovarian Cancer Test [R1].

The company has finished collecting blood samples in a United States trial. It has changed the test from five biomarkers to eight. It has received the first 125 test kits from its manufacturer. It is aiming to lodge the test with the United States Food and Drug Administration (FDA) in the first half of calendar 2027 [R4] [R5] [R9].

The numbers the company quotes for accuracy come from an earlier version of the test, measured on stored samples in Australia. The version going to the FDA has no published results yet. Three tests of the same kind are already cleared in the United States. Aspira Women's Health sells two of them and has sold the first, OVA1, for sixteen years. Its public accounts show it performed 22,515 tests in 2025 and recognised US$409 a test.

All prices in this piece are as at the close of ASX trading on 9 October 2026. The United States share price for Aspira Women's Health is the last close before that time.

WHAT THIS PIECE COVERS

1.00 THE CLINICAL PROBLEM, AN OVARIAN MASS BEFORE SURGERY

A doctor has to choose the surgeon before knowing whether an ovarian mass is cancer

2.00 THE COMPANY, THE BIOMARKER AND THE TEST

Cleo licenses one biomarker and plans to sell an eight-biomarker test as kits

3.00 THE PUBLISHED EVIDENCE BEHIND THE 95 PER CENT FIGURES

Two papers measured a four-biomarker test on stored samples from 334 Australian women

4.00 THE UNITED STATES TRIAL AND THE STEPS LEFT

Samples are collected, and the test that will be run on them is still being validated

5.00 THE FDA ROUTE AND THE TESTS ALREADY CLEARED

The FDA has cleared three tests of this kind, and their specificity was 50.8 to 75.5 per cent

6.00 PAYMENT FOR THE TEST IN THE UNITED STATES

Insurers pay for the test, and Aspira recognised US$409 a test against a Medicare rate of US$897

7.00 THE SUPPLIER, BIO-TECHNE

Bio-Techne makes the instrument and the kits, and its laboratory runs the validation

8.00 CASH, SPENDING AND THE SHARE PRICE

Cash of A$6.2 million at 30 June 2026 and spending of about A$1.7 million a quarter

9.00 SCREENING, THE THIRD MARKET CLEO DESCRIBES

Two large screening trials did not lower deaths, and Cleo's target is 99.6 per cent specificity

10.00 THE PEER COMPARISON, SCIENCE AND BUSINESS

Seven other groups have an ovarian cancer blood test on sale or in development

11.00 WHAT IS DUE NEXT

Nine events have a published date or target

HOW TO USE THIS PIECE

Medical, regulatory and finance terms are explained in plain English where they first appear. The main terms are collected again in one box near the end.

Each source has a marker such as [R1]. The marker appears in the text at the point the source is used. Click it to go to the full entry in the reference list.

Where the documents Cleo has published give two different figures for the same thing, this piece quotes both as they were published and names the document each came from. It does not attempt to resolve them.

Where this piece builds a model from released data instead of repeating a company statement, it says so at that point and labels it as a theoretical model, which is not a prediction.

This piece is built from public documents. We have not interviewed the company for it.

1.00 — THE CLINICAL PROBLEM, AN OVARIAN MASS BEFORE SURGERY

A doctor has to choose the surgeon before knowing whether an ovarian mass is cancer

A growth on or near an ovary is called an adnexal mass. It means a lump or cyst on an ovary, a fallopian tube or the tissue beside them. It is usually found on an ultrasound scan. Most are not cancer, which doctors call benign. A minority are cancer, which doctors call malignant, and a scan cannot always tell the two apart. The certain answer comes from a pathologist looking at the tissue after it has been removed.

A United States National Institutes of Health consensus statement in 1994 estimated that 5 to 10 per cent of American women would have surgery for a suspected ovarian growth in their lifetime. It estimated that 13 to 21 per cent of those women would be found to have ovarian cancer [R36]. The estimate is more than thirty years old. Our research has not found anything different.

Before the operation, the woman's doctor has to choose the surgeon. A gynaecological oncologist is a surgeon with extra training in cancers of the female reproductive organs. Craig Earle and colleagues studied 3,067 older American women who had surgery for ovarian cancer and published the result in the Journal of the National Cancer Institute in 2006. One woman in three was operated on by a gynaecological oncologist. Those women had a lower risk of death than women operated on by general surgeons. The gap against general gynaecologists was small [R37]. In that study the women operated on by the cancer specialist did better, most clearly against general surgeons.

This sorting step is called triage. A triage test helps a doctor decide whether a woman with a mass should be sent to the cancer specialist or can be operated on locally. In the United States the cleared tests are used in one direction. A high score sends a woman to the specialist. A low score does not replace the doctor's judgement. The diagnosis still comes from the pathologist after surgery.

The United States National Cancer Institute estimates 21,010 new cases of ovarian cancer and 12,450 deaths in the United States in 2026. Five-year relative survival is 52.0 per cent, which means that just over half of women are alive five years after diagnosis once other causes of death are allowed for. When the cancer is found while still confined to the ovary, the figure is 91.9 per cent. About 22 per cent of cases are found at that stage [R35].

Cleo's 2026 Annual Report gives an average five-year survival of 49 per cent, and cites the World Ovarian Cancer Coalition and the Ovarian Cancer Research Foundation [R1]. Its announcements say 51 per cent of patients die within five years [R7]. The two statements describe the same number.

The tools doctors use now

CA125 is a protein in the blood that often rises with ovarian cancer. It also rises with common non-cancerous conditions such as endometriosis, so a high reading can be a false alarm. A false alarm of this kind is called a false positive. We have written about Proteomics International (ASX: PIQ) and its blood test for endometriosis, in Promarker Endo. The Risk of Malignancy Index, or RMI, multiplies the CA125 reading by a score for the ultrasound and a score for whether the woman has been through menopause. ROMA and OVA1 are commercial blood tests that combine two or more proteins into one score. The FDA's figures for OVA1 and ROMA are in section 5.00.

2.00 — THE COMPANY, THE BIOMARKER AND THE TEST

Cleo licenses one biomarker and plans to sell an eight-biomarker test as kits

Cleo listed on the ASX on 22 August 2023 after raising A$12,000,000 by issuing 60,000,000 shares at 20 cents each [R18]. It has five directors [R1].

Adrien Wing is the non-executive chair and an accountant who has worked with small ASX companies for more than 25 years. Dr Richard Allman is the chief executive. He was previously chief scientific officer at Genetic Technologies, an ASX company that sold genetic risk tests. Dr Andrew Stephens is the chief scientific officer (PLATE 01). Professor Tom Jobling is head of gynaecological oncology at Monash Health and founded the Ovarian Cancer Research Foundation in 1999. Lucinda Nolan is a former chief executive of that foundation [R1].

CXCL10 and the Hudson Institute licence

A biomarker is something that can be measured in the body and that signals a disease. Cleo's central biomarker is a protein called CXCL10. It is a chemokine, which is a signalling protein that calls immune cells to a place in the body. Earlier work by Dr Stephens's group at the Hudson Institute had shown that DPP4, a protein that cuts other proteins, cuts CXCL10 into a form that blocks immune cells instead of calling them. In 2021 the group reported in the journal Diagnostics a way to measure the share of CXCL10 that was still in its working form. They called it the active ratio [R42].

Cleo holds the technology under licence. The 2026 Annual Report says the licence agreement with the Hudson Institute of Medical Research was signed on 29 August 2022 and gives Cleo exclusive rights to commercialise the technology. Cleo paid a deposit and then a further A$300,000 on signing, and issued 7,500,000 shares, valued at A$1,500,000, when it lodged its prospectus. A further A$1,500,000 is payable when the first product receives its first regulatory approval. One note in the report says this is paid in cash, and another says in cash or through the issue of shares. The agreement also carries a royalty of 3 per cent on net sales [R1]. For a shareholder that means a first approval triggers a payment of A$1,500,000, and each sale carries a 3 per cent royalty.

The Annual Report lists keeping this licence in force first among the things the business depends on [R1].

From five biomarkers to eight

On 23 March 2026 Cleo said it had expanded the test from five biomarkers to eight. It gave the reasons as analytical robustness, reproducibility and suitability for manufacture. A kit is the boxed set of materials a laboratory needs to run the test. Our reading is that a test built in a research laboratory has to give the same answer every time when thousands of kits are made in a factory. Adding markers reduces the test's reliance on any single one [R4].

The same release quotes Dr Allman. "The expanded biomarker panel improves assay robustness and reproducibility under real-world conditions, whilst maintaining strong clinical performance." An assay is a laboratory test. The release gives no accuracy figures for the eight-biomarker test. The documents we read do not name the eight biomarkers [R4].

How the test is run and sold

The test runs on an instrument called Ella, made by Bio-Techne, a company listed on the Nasdaq exchange in the United States. Ella is a benchtop machine that measures up to eight proteins from one small blood sample using a disposable cartridge. Cleo selected it in February 2026. Bio-Techne also manufactures the test kits [R16] [R6]. FIG. 01 shows the steps.

Cleo plans to sell kits to pathology laboratories. The Annual Report says the laboratories will perform the test and Cleo will earn revenue from the kits. Our reading is that the laboratory would bill the insurer and Cleo would not. Cleo has not published a kit price [R1].

Cleo describes three markets, in the order it intends to enter them (FIG. 02). The first is triage before surgery. The second is monitoring women after treatment to detect a relapse. The third is screening women who have no symptoms. The Annual Report says the dollar values are estimates by Cleo management, based on the number of patients or tests and an indicative price per test. It does not state the currency [R1].

For the triage market Cleo relies on insurance claims data from Norstella, a data company it commissioned. The December 2025 quarterly report says about 3.4 million American women a year see a doctor with a suspected ovarian or adnexal mass, and about 2.0 million of them go on to further diagnostic investigation. Cleo treats the 2.0 million as the group its first test could be used on [R15]. The FDA category is narrower. It covers women for whom surgery is planned [R27]. The documents we read do not say how many of the 2.0 million go on to surgery.

3.00 — THE PUBLISHED EVIDENCE BEHIND THE 95 PER CENT FIGURES

Two papers measured a four-biomarker test on stored samples from 334 Australian women

Sensitivity is the share of women who have cancer that the test correctly flags. Specificity is the share of women who do not have cancer that the test correctly clears. A test with low specificity sends many healthy women to the cancer specialist.

Cleo's June 2025 presentation states "95% sensitivity and 95% specificity compared to current CA125 test (94% / 82%)" [R3]. The figures come from a paper by Dr Stephens and eight co-authors, "A Novel Predictive Multi-Marker Test for the Pre-Surgical Identification of Ovarian Cancer", published in the journal Cancers in November 2023 [R19].

The study measured stored blood from 334 women. The samples came from the Ovarian Cancer Research Foundation tissue bank at the Hudson Institute, which stores donated samples. Of the 334 women, 170 had a benign mass and 164 had cancer. The test combined CA125, a second protein called HE4, an immune signalling protein called IL-6, and the CXCL10 active ratio. The paper calls this a four-biomarker panel. A later paper by the same group describes it as five individual measurements. The first paper's summary lists CXCL10 twice, as active and as total, which makes five [R19] [R20].

FIG. 03 charts the main result. The panel scored 95 per cent on both measures. CA125 on its own scored 94 per cent sensitivity and 82 per cent specificity. ROMA scored 93 per cent and 92 per cent. The panel found about the same number of cancers as CA125. Its advantage was in clearing women who did not have cancer. Against ROMA the gap was two points on sensitivity and three on specificity [R19].

The limits of the 2023 study

The samples were retrospective. That means the blood had been collected and stored in earlier years, and the researchers already knew which women had cancer. Every woman in the study had already been referred to a gynaecological oncologist for surgery. The blood was plasma taken once the woman was under anaesthetic for her operation. The United States trial register lists serum, which is a different preparation of blood [R19] [R21].

Almost half the women had cancer, 164 of 334. The authors write that in ordinary practice benign masses outnumber cancers by about nine to one. This affects two further measures. Positive predictive value is the share of positive results that turn out to be cancer. Negative predictive value is the share of negative results that are truly clear. Both depend on how common cancer is among the women tested, so the values in the paper apply to that group of women only [R19].

Of the 164 cancers, 143 were Stage III or IV and 126 were of the serous type. Stage III and IV mean the cancer has spread beyond the pelvis. The paper does not report a borderline tumour group. It gives a range of 91 to 98 per cent around the sensitivity figure and 90 to 98 per cent around the specificity figure [R19].

There was no second, separate group of patients to check the result on. The authors first checked the method by cross-validation. This builds the formula on part of the data, tests it on the part held back and repeats the process. That check gave 93.0 per cent sensitivity and 95.2 per cent specificity. The authors then rebuilt the formula on all 334 women and scored it on the same 334 women. The 95 per cent figures come from that step. The paper's Table 3 gives the sensitivity from that step as 93.9 per cent and its Table 4 gives 95 per cent. Both are given here as they appear. The cut-off score that separates high risk from low risk was chosen on the same data. The authors write, "These findings now require validation using an independent cohort" [R19].

In women who had not reached menopause the panel's sensitivity was 81 per cent, the same as ROMA and below CA125 at 91 per cent. There were 115 such women in the study and 32 of them had cancer. The 81 per cent is measured on those 32, and the paper gives a range of 64 to 93 per cent around it [R19]. In plain terms, in younger women the research test found fewer cancers than CA125 alone in this study.

The study had 17 Stage I cancers. Stage I means the cancer is confined to the ovary. The paper says the panel correctly classified 13 of them. It prints that as 81 per cent. Thirteen divided by seventeen is 76.5 per cent, by our arithmetic. Both figures are given here as they appear [R19].

The paper states the interests of its authors. Dr Stephens and Dr Allman are described as employees and executive board members of Cleo. Professor Jobling is a non-executive director. The statistician was contracted by Cleo. The research funding came from the Ovarian Cancer Research Foundation, the National Health and Medical Research Council and the Victorian Government [R19].

The second paper and two presentation slides

The second paper, "Utility of a Multi-Marker Panel with Ultrasound for Enhanced Classification of Adnexal Mass", appeared in Cancers in May 2024. It did not recruit new patients. It took the 169 women from the first study who had ultrasound records and looked at the same scores again. On those women the panel scored 91.1 per cent sensitivity and 95.6 per cent specificity. The authors describe the group as biased towards high-risk cases [R20].

Ten of the 169 women had early-stage cancer. The panel combined with ultrasound identified nine of them. The June 2025 presentation shows a bar of 90.0 per cent for early detection against about 57 per cent for CA125 with ultrasound. It cites this paper for the 90.0 per cent and a separate paper by Burke and others for the 57 per cent. Our reading is that the 90.0 per cent is the nine women out of ten [R20] [R3].

A further slide in the same presentation (FIG. 04) shows sensitivity of 84.4 per cent before menopause and 98.5 per cent after menopause, with specificity fixed at 90 per cent. Fixing specificity means each test's cut-off is set so that it clears 90 per cent of benign masses, and the tests are then compared on sensitivity alone. The slide's footnote cites the 2023 paper, a 2022 Cochrane review by Davenport and others [R41], and two papers on the older tests. Our research did not find those two figures in the text or tables of the 2023 paper. We did not read its supplementary file [R3] [R19].

The bars for the other tests come from other studies on other women, so the slide does not compare the tests on the same samples. The 2023 paper does make that comparison at 95 per cent specificity. It says ROMA's sensitivity stayed under 90 per cent and that of CA125 and the RMI under 80 per cent [R19].

THE PUBLISHED FIGURES ARE FOR AN EARLIER VERSION OF THE TEST

The published figures describe a research test of four biomarkers, measured on stored Australian plasma from women already referred to a specialist. Most of the cancers were advanced.

The test going to the FDA has eight biomarkers, is made in a factory and is being run on blood collected from women at United States clinics before their surgery.

No accuracy figures have been published for that test. The United States trial is the first measurement of it.

4.00 — THE UNITED STATES TRIAL AND THE STEPS LEFT

Samples are collected, and the test that will be run on them is still being validated

A pivotal trial is the study a regulator relies on when it decides whether a product works. Cleo's is registered on ClinicalTrials.gov, the United States government register of clinical studies, under the number NCT06566716 [R21].

The register describes an observational study. Women aged 18 or over with an ovarian cyst or adnexal mass that needs surgery give blood before the operation. After surgery the test score is compared with the pathologist's finding. The study started on 6 September 2024. The listed outcomes are sensitivity, specificity, positive and negative predictive value, and a comparison with CA125 and the RMI. Lindus Health, a company that runs trials for sponsors, is listed as collaborator [R21].

The samples were collected prospectively. The blood was taken first and the diagnosis was learned afterwards, in women booked for surgery. The published papers used samples collected with the diagnosis already known. The trial samples have been stored and will be tested later on the finished kit. The register lists sensitivity and specificity as secondary outcomes and states no target for them [R21].

The figures Cleo has published for the trial

Cleo's documents and the public register give different figures for the same trial. TABLE 01 sets them out as published. The register was last updated on 4 February 2025 and now shows the study status as unknown, which is the label the register applies when a sponsor has not confirmed a record for a long period [R21].

The steps between now and a submission

Cleo has set out five steps (FIG. 05). Analytical validation comes first. It tests the kit itself for precision, reproducibility and robustness, across three separately manufactured batches. The algorithm is finalised next. The algorithm is the formula that turns eight measurements into one score. Clinical validation follows, which runs the stored trial samples through the finished kit. The results are then analysed and the submission is lodged [R8] [R9].

Cleo says the formula will be fixed before the trial samples are tested [R9]. The FDA's guidance for this category says the samples used to check a test must be different from the samples used to build it [R50]. Cleo has not said which samples the eight-biomarker formula is built on. Its September 2025 quarterly report said it had secured about 1,600 stored samples to support refinement of the test. About 1,400 of them came from two Australian biobanks, by our arithmetic [R15]. The documents we read do not say whether the laboratory will be kept unaware of each woman's diagnosis. The 2023 study built and tested its formula on the same samples.

Clinical validation will be done by Asuragen, a laboratory owned by Bio-Techne. It has three parts. About 600 samples come from the trial. About 570 come from patients with other benign or malignant conditions, to check that the test does not react to them. About 300 come from healthy people [R10].

Cleo has not published how many of the trial samples came from women who turned out to have cancer. That number decides how precisely sensitivity can be measured. As a theoretical model only, the 1994 estimate of 13 to 21 per cent [R36] would put 78 to 126 cancers among 600 samples. The 2023 paper's figure of about one cancer in ten would put about 60. The study behind the FDA clearance of the second-generation OVA1 test had 92 cancers among 493 women [R24]. This is our model and is not a company figure.

The submission target has moved from 2026 to the first half of 2027

The June 2025 presentation expected the United States trial to be completed in 2025 [R3]. The September 2025 quarterly report spoke of a submission in 2026 [R15]. Since 13 July 2026 the target has been the first half of calendar 2027 [R8].

On 13 July 2026 Cleo expected analytical validation to start in August and take about four months. On 3 September it received the first batch of 125 kits and said the second and third batches were expected in the December quarter, with validation targeted for completion by the end of calendar 2026. On 10 September it said the first batch was going through internal checks ahead of the formal start. Cleo's most recent announcement at 9 October 2026 was dated 30 September and did not report a start or a finish [R8] [R9] [R10] [R12]. So at 9 October 2026 Cleo had not confirmed that analytical validation had started.

Cleo has met the FDA twice ahead of its submission. These pre-submission meetings let a company ask the regulator about its plans. The September 2025 quarterly report says the second meeting covered trial design, clinical specificity, sample stability, the use of stored samples and the intended use of the test, which is the statement of who the test is for and what it is used to decide. The report describes the feedback as positive and detailed. The FDA does not publish these meetings, so the description is the company's [R15].

5.00 — THE FDA ROUTE AND THE TESTS ALREADY CLEARED

The FDA has cleared three tests of this kind, and their specificity was 50.8 to 75.5 per cent

Cleo intends to use the FDA's 510(k) route. The FDA regulates a diagnostic test as a medical device. Under the 510(k) route a company shows that a new device does the same job, about as safely and as well, as one already legally on the market. The older device is called the predicate. A product that passes is described as cleared. Approval is a different and longer FDA process used for higher-risk devices [R27]. Another ASX company, Echo IQ, holds a 510(k) clearance for its EchoSolv AS product, which we covered in Echo IQ (ASX EIQ).

The category exists because of OVA1. In September 2009 the FDA classified OVA1 as the first "ovarian adnexal mass assessment score test system" through its De Novo process, which is the route for a new kind of device that has no predicate. The next two tests used OVA1 as their predicate, and the later versions of ROMA used ROMA. The FDA's database holds six records in the category. The most recent decision was in June 2016 [R22] [R25].

Cleo's June 2025 presentation names ROMA as its predicate [R3]. ROMA is made by Fujirebio Diagnostics and combines CA125 and HE4 with menopausal status. The FDA cleared it in September 2011 [R23].

The scores in the FDA decision summaries

The FDA publishes a decision summary for each clearance. TABLE 02 and FIG. 06 take the figures from those summaries. Two columns are shown. One is the test on its own. The other is the test used together with the doctor's assessment, which is the use the FDA cleared [R22] [R23] [R24].

The cleared tests find most cancers. They clear fewer of the benign masses. In the FDA's OVA1 study the test on its own cleared about half of the women with benign masses. The best of the three, ROMA, cleared three in four. Cleo's research test scored 95 per cent specificity in the 2023 paper. If the eight-biomarker test scored near that in the United States trial, it would clear more benign masses than any of the three cleared tests did in its FDA study.

The 95 per cent comes from a different study, on different patients, with an earlier version of the test. The 2023 paper shows how much the patient group matters. ROMA scored 92 per cent specificity on Cleo's 334 stored samples and 75.5 per cent in its FDA study. On the same samples the gap between Cleo's research test and ROMA was three points, 95 against 92. The paper's ranges of uncertainty for the two overlap, and it reports no statistical test of the difference [R19] [R23].

A clearance in this category covers use beside a doctor's assessment

The FDA's summary for OVA1 says the test "should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery" [R22]. The regulation for the category requires a warning of that kind on the labelling and advertising of every test in it [R27].

Cleo's presentation lists a secondary measure for its trial. The test will be assessed alongside the doctor's assessment and compared with the doctor's assessment alone [R3].

A clearance through this route would cover women who have a mass, are booked for surgery and have not yet been referred to a cancer specialist. The regulation describes the test as an add-on for cases where the doctor's assessment has not pointed to cancer [R27]. Under the FDA's guidance a woman is treated as high risk if either the doctor or the test says so [R50]. A low score does not overrule a doctor who suspects cancer. A clearance would not cover screening, which is a separate program discussed in section 9.00.

The five earlier 510(k) reviews took 122 to 375 days

FIG. 07 shows the days between the FDA receiving each submission in this category and deciding on it. The five 510(k) reviews took 122 to 375 days. The OVA1 petition of 2009 took 51 days, but that followed an earlier filing that its maker dated to June 2008. Across all devices, the FDA's report to Congress gives an average of 139 days to a 510(k) decision for submissions received in its 2024 financial year [R25] [R26]. Four of the five reviews took longer than that average.

This is a theoretical model only. It starts with a submission lodged on the last day of Cleo's target period, 30 June 2027. The two earlier submissions that brought a new formula took 289 and 375 days. That gives a decision between 14 April 2028 and 9 July 2028. The three faster reviews, of 122 to 329 days, moved an existing formula to a new analyser. The fastest of them would give 30 October 2027. An earlier submission moves every date earlier. The model is ours. It does not come from the company and it does not predict what the FDA will do [R25].

The Ella instrument and its regulatory status

The three later versions of ROMA were each cleared for a named laboratory analyser, and each needed a separate 510(k) [R25]. Cleo's test will run on Ella. Bio-Techne's material describes the standard Ella as a research instrument, which means it is sold for laboratory research and not for testing patients. A version received the European CE-IVD mark for diagnostic use in February 2026, and the same Bio-Techne release says the assays that run on it "remain for research use only" [R31]. Cleo calls it the "Ella diagnostic platform" [R10].

The FDA's guidance for this category says a clearance is limited to the specific kits and instruments that were tested [R50]. The instrument is described in the kit's submission and named on its label. Cleo's documents do not say how Ella will be covered. Our search of the FDA's 510(k) database on 11 October 2026 for Ella and its maker found no record [R25].

6.00 — PAYMENT FOR THE TEST IN THE UNITED STATES

Insurers pay for the test, and Aspira recognised US$409 a test against a Medicare rate of US$897

In the United States a laboratory test is paid for by the patient's insurer, called a payer. The largest is Medicare, the federal program mainly for people aged 65 and over. Each test is billed under a five-character CPT code. Medicare publishes a price for each code on its Clinical Laboratory Fee Schedule. Private insurers negotiate prices with each laboratory. Payment by an insurer is called reimbursement.

A test is paid for reliably when it has a billing code, the code has a price and each payer has agreed to cover it. The last step is called a coverage decision. FDA clearance is separate from all three.

Cleo plans to launch under billing code 81599

On 20 May 2026 Cleo said it would launch after clearance under code 81599. This is a general code for multi-marker tests that do not yet have a code of their own. Cleo said payment under it is decided payer by payer, and that comparable tests including OVA1 "have reported reimbursement levels in the range of ~US$500–$900 per test (payer dependent)". It plans to apply for a separate code about 6 to 12 months after launch [R7]. One passage of the Annual Report puts it as "up to US$900 per test" [R1].

Code 81599 does not appear on the Medicare fee schedule for 2026, so it has no national price [R29]. The Medicare claims manual says unlisted laboratory codes are held for review and priced by the regional Medicare contractor [R30]. A 2017 Medicare instruction names code 81599 and requires the name of the test on each claim [R52].

Aspira recognised less than half the Medicare rate

The Medicare fee schedule for 2026 lists OVA1, code 81503, at US$897.00. The second-generation test, code 0003U, is listed at US$950.00. Code 81500 is listed at US$260.50. Its description is a test of CA125 and HE4 with menopausal status, which matches ROMA, the test Cleo names as its predicate [R29]. The top of Cleo's range is close to the Medicare rate for OVA1.

OVA1 is sold by Aspira Women's Health, a United States company that runs the tests it bills for in its laboratory in Texas. It bills insurers itself, which Cleo does not plan to do. It files accounts with the Securities and Exchange Commission, the United States company regulator. Its annual report for 2025 gives the average unit price, which is the revenue it recognised per test across all payers. In 2025 it was US$409 [R28]. That is 46 per cent of the Medicare rate, by our arithmetic. The average covers every payer. That includes private insurers, patients who pay for themselves and Medicaid, the public program for people on low incomes. It also includes tests that were not paid in full. Aspira does not publish the share of its tests that were paid.

FIG. 08 and TABLE 03 show eight years of those accounts. OVA1 went on sale in March 2010. In 2025, its sixteenth year, Aspira performed 22,515 tests and reported product revenue of US$9.2 million. Test numbers rose every year from 2018 to a peak of 24,305 in 2024, then fell [R28]. Aspira's peak of 24,305 tests in a year compares with the 2.0 million women a year that Cleo counts as its first market.

Aspira has had Medicare coverage for OVA1 since 2013. The US$897 Medicare rate has held since January 2018. By 2022 the company reported coverage for about 215 million people across public and private payers [R28].

Aspira reported a net loss in every year in TABLE 03. Its annual reports for 2022 to 2025 each say there is substantial doubt about its ability to continue as a going concern, which is the accounting phrase for a risk that a company cannot keep operating without new money. Its shares were removed from the Nasdaq exchange in April 2025 [R28]. Put together, in the eight years in TABLE 03, Medicare coverage and higher test numbers did not bring Aspira a profit.

Cleo will sell kits and will not bill insurers

Cleo plans to sell kits to laboratories and will not bill insurers itself. Its revenue per test will be the kit price, which has not been published. Neither US$897 nor US$409 is a forecast of what Cleo will receive. The laboratory buys the kit and bills the payer. It carries the risk that the payer does not pay.

The kit model means a laboratory that has the cleared version of the instrument could offer the test. Aspira runs the tests it bills for through its laboratory in Texas. It has also offered the tests to partner laboratories through a platform it calls Aspira Synergy. Aspira's annual report says its Medicare coverage applies nationally because every test it bills is run in Texas under one Medicare contractor [R28]. Laboratories in other regions answer to other contractors.

The clinical case may be stronger, within a limit. Under the FDA's rule the test adds referrals to those the doctor already makes. The combined result cannot clear more benign masses than the doctor's assessment alone. In the three FDA studies the doctors alone cleared 82.7, 84.3 and 92.8 per cent of benign masses [R22] [R23] [R24]. A test with high specificity would add fewer false alarms on top of that. The FDA's guidance asks for a meaningful gain in negative predictive value and an acceptable loss in positive predictive value [R50]. That depends on the trial result.

OvaWatch has a code and a Medicare rate, and its coverage decision is still under review

Aspira's newer test, OvaWatch, shows how long the steps took for a company already selling OVA1. OvaWatch is a blood test for women whose mass looks benign or uncertain at first assessment. Aspira began billing it under a code of its own in April 2023. Medicare set the rate at US$897 in November 2023, effective January 2024, for claims that meet its coverage requirements. In August 2026 Aspira reported that Medicare's coverage decision for OvaWatch was still under review [R28]. For OvaWatch a code and a Medicare rate have not yet brought a Medicare coverage decision.

Cleo commissioned a health economic study from EntityRisk, a firm that models the costs and savings of medical products. Insurers use such studies when they decide on coverage. The December 2025 quarterly report expected the study in the first quarter of calendar 2026. The Annual Report lists the results for the second half of calendar 2026. They had not been released at 9 October 2026 [R15] [R1].

7.00 — THE SUPPLIER, BIO-TECHNE

Bio-Techne makes the instrument and the kits, and its laboratory runs the validation

Bio-Techne Corporation is a life sciences supplier based in Minnesota. It reported net sales of US$1,215.0 million for its financial year to 30 June 2026. It bought Asuragen, a diagnostics company in Austin, Texas, in 2021 [R31].

Bio-Techne has three roles in Cleo's program. It makes the Ella instrument and manufactures the test kits. Its Asuragen laboratory will run the clinical validation. Asuragen holds CLIA certification, the United States federal standard a laboratory must meet to test patient samples [R6] [R10] [R31].

Cleo uses an existing manufacturer and does not have to build a factory. The trial samples are tested by a certified laboratory owned by the kit's manufacturer, and Cleo's staff do not run them.

Cleo depends on one supplier for its kits and its instrument. The agreements are described in its releases as a staged manufacturing program and a statement of work. Their prices, volumes and terms have not been published [R6] [R10]. The 13 July 2026 release made the timetable "subject to any changes in the manufacturing timeline from Bio-Techne" [R8].

Merck KGaA is buying Bio-Techne

Bio-Techne is being bought. Its annual report says it signed a merger agreement on 25 June 2026 with Merck KGaA of Darmstadt, Germany, at US$73.00 in cash per share. Bio-Techne announced shareholder approval on 23 September 2026. Bio-Techne expects the merger to complete in late 2026 or early 2027, subject to the remaining regulatory approvals [R31]. Merck KGaA is the German group and is a separate company from Merck and Co of the United States.

Cleo's announcements between 13 July and 30 September 2026 do not mention the takeover. None of the documents we read says whether the change of owner affects Cleo's supply or its timetable [R31].

8.00 — CASH, SPENDING AND THE SHARE PRICE

Cash of A$6.2 million at 30 June 2026 and spending of about A$1.7 million a quarter

Cleo has no product on sale. Its income is interest on its cash and a yearly refund under the Australian research and development tax incentive, a federal scheme that pays back part of what a small company spends on eligible research. For the year to 30 June 2026 it reported a loss of A$5,936,480, up from A$3,999,134 the year before. Research and development spending was A$4,916,424, up from A$2,882,114. The tax incentive brought in A$1,717,150 [R1].

An ASX company at this stage lodges a cash flow report each quarter, called an Appendix 4C. FIG. 09 charts Cleo's last five. Cash was A$6.224 million at 30 June 2026. The June quarter used A$1.672 million in operating activities. The form divides one by the other and Cleo reported 3.72 quarters of funding [R2] [R15].

An option is a right to buy a new share at a fixed price. Using that right is called exercising the option. A notice lodged on 24 August 2026 shows holders exercised 5,271,661 options at 30 cents, which is A$1,581,498 by our arithmetic. The notice lists four directors or their entities among the holders. Lucinda Nolan and Tom Jobling are listed with 1,500,000 each. The notice names Ms Nolan as Lucinda Frawley. Richard Allman is listed with 227,273 and Andrew Stephens with 136,364. A further 8,449,589 options of the same series lapsed without being exercised on 22 August 2026 [R14]. More options in the series lapsed than were exercised.

The 2026 Annual Report, signed on 20 August 2026, says the directors prepared cash flow forecasts for the following 12 months that show a positive cash balance throughout. It says the forecasts include assumptions about the tax incentive, that the timing of development spending can be managed, and that the company has raised capital before. The auditor's opinion was unmodified [R1].

A theoretical model of how long the cash lasts

This is a theoretical model built from the released figures. It is not a company forecast.

Cash at 30 June 2026 plus the option money is A$7.81 million. Divided by the June quarter's spending of A$1.672 million, that is 4.67 quarters, which runs to about the end of August 2027. Without the option money the company's reported 3.72 quarters runs to early June 2027.

The model leaves out the next tax refund, which would extend the cash. We have used last year's A$1,717,150 as a marker only. That would take the total to A$9.52 million, which is 5.7 quarters and runs to about early December 2027. The Annual Report shows research spending rose by about 70 per cent in the year, so the next claim may be larger. The report does not say how much of the spending in the United States is eligible [R1].

The model leaves out the A$1,500,000 payable to the Hudson Institute on first regulatory approval. One note in the report says cash and another says cash or shares. It also leaves out the cost of a United States launch. Both would shorten it. The model also assumes spending stays at the June quarter's rate while the company pays for kits and clinical validation.

The theoretical model in section 5.00 put an FDA decision between 14 April 2028 and 9 July 2028 for a submission lodged on the last day of the target period. Without a tax refund, the cash in this model is used up at about the end of August 2027. With a refund the size of last year's it lasts to about early December 2027. Both dates fall before that range. On the fastest of the earlier FDA reviews the decision would come on 30 October 2027, which falls between the two cash dates. An earlier submission would move the FDA dates earlier. The directors' forecast, described above, covers the 12 months to about August 2027. Each quarterly report will show the actual cash and spending.

The annual general meeting is on 26 November 2026. A placement is a sale of new shares to selected investors. A company can normally issue new shares equal to 15 per cent of its capital in a year without a shareholder vote. One resolution asks shareholders to approve a further 10 per cent for the following year. Another asks them to ratify the December 2025 placement, which restores the capacity that placement used up [R17].

The share price

Cleo raised A$5 million in December 2025 by placing 8,333,334 shares at 60 cents with institutional and high net worth investors. The price was an 8.4 per cent discount to the average of the previous 15 trading days. Petra Capital managed the placement and received 833,333 options exercisable at 90 cents [R13].

The shares closed at 31.5 cents, which is 48 per cent below the 60 cents that investors paid in the December 2025 placement. The 12-month high was a close of 86.5 cents on 19 January 2026 and the low was 28 cents on 29 September 2026. With 142,383,746 shares on issue, the market value is A$44.9 million by our arithmetic [R40] [R14]. FIG. 10 shows the price since listing.

The chair, Adrien Wing, has an interest in 14,250,000 shares according to the Annual Report, which is about 10 per cent of the shares now on issue. The Hudson Institute's investment company is listed with 6,500,000 shares [R1].

9.00 — SCREENING, THE THIRD MARKET CLEO DESCRIBES

Two large screening trials did not lower deaths, and Cleo's target is 99.6 per cent specificity

Screening means testing women who have no symptoms and no known mass. A screening test is used on far more women and very few of them have cancer, so it needs much higher specificity than a triage test. On 24 September 2026 Cleo said it had started building a prototype screening test. It called screening a $150 billion global market, with no currency stated. The Annual Report says such values are management estimates [R11] [R1].

The first stage is a proof-of-concept study, an early study to show the idea can work, on 250 patients, chosen to include many Stage I cancers. Cleo expects those results early in the December quarter of 2026 and aims to settle the design of the test by the end of calendar 2026. On 30 September it said it had filed two provisional patent applications for the screening work. A provisional application is an early filing that has not been examined. The placement release of December 2025 listed the screening test among the uses of the money raised [R11] [R12] [R13].

Cleo says it has access to stored blood from two large past trials, the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) through University College London, and the Prostate, Lung, Colorectal and Ovarian (PLCO) trial in the United States [R11]. Both trials were run to find out whether screening saves lives.

UKCTOCS and PLCO found no fall in deaths

UKCTOCS is the largest ovarian screening trial ever run. Professor Usha Menon of University College London and colleagues published its final result in The Lancet in 2021. Between 2001 and 2005 it assigned 202,638 women past menopause to yearly CA125 testing with follow-up scans, yearly ultrasound, or no screening. The women were followed for a median of 16.3 years [R32].

The blood test group found cancers earlier. The rate of Stage I and II cancers was 39.2 per cent higher than in the group with no screening. Deaths did not fall. In each of the three groups 0.6 per cent of women died of ovarian or tubal cancer. The authors concluded that "general population screening cannot be recommended" [R32].

The PLCO trial in the United States also found no fall in deaths, and it counted the operations that followed false-positive results. Saundra Buys and colleagues published it in the Journal of the American Medical Association in 2011. Among 78,216 women there were 118 ovarian cancer deaths in the screened group and 100 in the group that was not screened. Of 3,285 women with a false-positive result, 1,080 had surgery, and 163 of those had at least one serious complication [R33].

In 2018 the US Preventive Services Task Force, the panel whose ratings guide American insurers, recommended against screening women without symptoms. Its page showed no update in progress when read on 9 October 2026 [R34].

Finding cancers earlier was not enough to lower deaths in UKCTOCS. The Task Force based its 2018 recommendation on deaths [R34]. Our reading is that a new screening test would need evidence on deaths before that recommendation changed. UKCTOCS took twenty years from its first recruit to its final paper.

At 99.6 per cent specificity a test still flags 400 women without cancer in 100,000

Cleo has set minimum targets of 75 per cent sensitivity and 99.6 per cent specificity for screening the general population, and 90 per cent on both for women at high inherited risk [R11]. The 99.6 per cent figure comes from the research literature. Robert Bast and colleagues restated it in the journal Cancer Epidemiology, Biomarkers and Prevention in 2020, as the level needed for one cancer to be found for every ten operations [R39].

Ovarian cancer is rare, so even a small false-positive rate produces many more false positives than cancers. FIG. 11 works it through for 100,000 women past menopause, using the figure of 1 cancer in every 2,500 women past menopause that the same literature uses. That is 40 cancers. A test with 75 per cent sensitivity finds 30 of them. A test with 99.6 per cent specificity still gives a positive result to 0.4 per cent of the 99,960 women without cancer, which is 400 women. So 430 women are told they may have cancer and 30 of them do. That is 7 per cent, by our arithmetic.

Our arithmetic gives 7 per cent of positive results, and the literature states one cancer for every ten operations. Both are given here. Every tenth of a percentage point of specificity changes the number of healthy women sent for follow-up by about 100 in every 100,000.

The research version of Cleo's triage test scored 95 per cent specificity among women who already had a mass. Cleo is developing the screening test as a separate program with separate targets, and has published no results for it [R11] [R19].

Others working on the same samples

Other groups have used the UKCTOCS samples. A study of a test developed by Mercy BioAnalytics, a United States company, was published in the journal Gynecologic Oncology in 2025. The test found 82.9 per cent of 41 cases of the most common aggressive type of ovarian cancer and had specificity of 97.7 per cent in 1,176 women without cancer. CA125 scored 68.3 per cent and 95.6 per cent on the same samples [R38].

10.00 — THE PEER COMPARISON, SCIENCE AND BUSINESS

Seven other groups have an ovarian cancer blood test on sale or in development

Cleo is one of several companies working on a blood test for ovarian cancer. Aspira's annual report for 2025 names Fujirebio Diagnostics as the maker of the competing cleared test. It names four companies as working on ovarian cancer tests, AOA Dx, ClearNote Health, Cleo and Mercy BioAnalytics [R28]. Our research added two more, InterVenn Biosciences in the United States and INOVIQ on the ASX. We did not search exhaustively.

The companies divide into two groups by what the test is for. A triage test is used on a woman who already has a mass or symptoms. A screening test is used on women with no symptoms. Cleo's first product is a triage test, and its screening work is at an earlier stage.

The tests and their published accuracy

TABLE 04 sets out what each test measures and the accuracy figures each group has published. The tests use different kinds of marker. Cleo, Aspira and Fujirebio measure proteins. InterVenn measures sugar molecules attached to proteins. AOA Dx measures fats and proteins. Mercy BioAnalytics reads proteins carried on tiny particles that cells release into the blood. INOVIQ reads genetic material from inside such particles and adds CA125. ClearNote reads chemical marks on fragments of DNA in the blood.

In TABLE 04 the only tests with FDA clearance are the older protein tests, and their specificity is 50.8 to 75.5 per cent. Each newer test that has published figures measured them on stored samples. That includes Cleo's. Cleo and InterVenn have collected samples in a prospective study. Mercy BioAnalytics has FDA permission to start one. AOA Dx said in May 2026 that it had enrolled the first participant in a prospective sample collection study, which our research did not find on ClinicalTrials.gov [R51]. InterVenn registered a 1,025-woman study that is listed as completed, and our research has not found its results [R45].

INOVIQ is another ASX company developing an ovarian test of its own. On 1 July 2026 it said the 1,200 samples in its validation study were unsuitable because of how they had been stored and handled at the sample banks. On 30 September 2026 it gave a new target of a laboratory-developed test in the United States in the first half of calendar 2028 [R43]. Cleo's trial collected blood at clinics under one protocol and then stored it. The trial began in September 2024 and testing is planned for the first half of calendar 2027. Cleo's September 2025 quarterly report lists sample stability among the topics of its second FDA meeting [R15]. Cleo has not published stability results for the eight biomarkers.

Market value and cash of the listed companies

TABLE 05 compares the listed companies. FIG. 12 charts the four ASX companies. BCAL Diagnostics and Rhythm Biosciences are not ovarian test developers. Each has a cancer blood test on sale. BCAL's test is for breast cancer and it resells ClearNote's ovarian test. Rhythm's test is for bowel cancer [R44] [R48]. We wrote about BCAL in January 2026, in BCAL Diagnostics expands early cancer detection.

The four ASX companies are small. Each is valued at between A$22 million and A$45 million, and each used A$1.7 million to A$2.5 million in the June quarter. Aspira is the only one of the five with a cleared ovarian test and regular sales, and the market values it at US$12.1 million. Aspira held US$0.5 million at 30 June 2026 and used US$2.0 million in that quarter. Among the four ASX companies Cleo has the second-largest cash balance.

The private companies do not publish accounts. Mercy BioAnalytics announced funding rounds of US$41 million in 2023 and US$59 million in 2025. ClearNote Health said in May 2026 that it had raised more than US$185 million in total. Medicare has set a price of US$1,160 for ClearNote's ovarian test [R47] [R49]. That is above the US$897 Medicare rate for OVA1. A price is separate from a coverage decision, and our research did not find one for this test.

INOVIQ's ovarian test is at an earlier stage than Cleo's. In triage, the cleared tests of Aspira and Fujirebio are on sale and InterVenn's laboratory-developed test is in limited release. In screening, Mercy BioAnalytics has FDA permission to begin its pivotal study, and Cleo's screening test is at the prototype stage.

11.00 — WHAT IS DUE NEXT

Nine events have a published date or target

TABLE 06 lists the events that Cleo or its documents have put a date on.

THE CASE FOR THE COMPANY

The cleared tests score 50.8 to 75.5 per cent on specificity in the FDA summaries. Cleo's research test scored 95 per cent in the 2023 paper, on an earlier version and a different group of women. ROMA scored 92 per cent on that group [R22] [R23] [R24] [R19].

The trial samples are already collected, before surgery, from the women the test is meant for. Enrolment passed the stated minimum of 500 women [R5] [R21].

The formula will be fixed before those samples are tested, and a certified laboratory owned by the kit's manufacturer will run them [R9] [R10].

The FDA category exists, has a predicate and has cleared five submissions through the 510(k) route. Cleo has met the FDA twice before lodging [R25] [R15].

Manufacturing is with Bio-Techne, which reported net sales of US$1,215.0 million for its last financial year, so Cleo does not have to build a factory [R6] [R31].

Four directors or their entities exercised options at 30 cents in August 2026. The auditor's opinion on the 2026 accounts was unmodified, which means the auditor raised no qualification, and the directors' forecast shows cash through the following 12 months [R14] [R1].

THE STANDING COUNTERARGUMENT

No accuracy result exists for the eight-biomarker test that is being submitted. The published figures are for an earlier four-biomarker test on 334 stored samples, with no separate group of patients to confirm them. The authors wrote that the findings needed validation in an independent group [R19].

The study had 17 Stage I cancers, and in women before menopause the research test's sensitivity was 81 per cent against 91 per cent for CA125 [R19].

The timetable has moved. The June 2025 presentation expected the trial to be completed in 2025, and the submission target has gone from 2026 to the first half of calendar 2027 [R3] [R15] [R8]. Cleo's figures for the trial differ between documents, as TABLE 01 shows.

Clearance in this category is for use beside a doctor's assessment. A doctor who suspects cancer still refers the woman when the score is low [R50]. Clearance brings no billing code, price or insurance coverage. Code 81599 has no national Medicare price [R22] [R29].

Aspira has sold OVA1 for sixteen years with Medicare coverage and a Medicare rate of US$897. It recognised US$409 a test in 2025, performed 22,515 tests, reported a net loss of US$12.8 million and its accounts state substantial doubt that it can continue as a going concern. Aspira bills insurers itself and Cleo will sell kits, so the two businesses are not the same [R28].

On our theoretical model, without a tax refund the cash is used up at about the end of August 2027. A refund the size of last year's extends it to about early December 2027. Both dates fall before the modelled FDA decision dates of April to July 2028. The AGM on 26 November 2026 will vote on a 10 per cent placement facility [R17].

Cleo depends on one supplier for its kits, its instrument and its validation testing, and that supplier is being bought by Merck KGaA [R31].

Bio-Techne describes the standard Ella as a research instrument [R31]. The FDA's guidance says a clearance is limited to the kits and instruments that were tested [R50]. Cleo's documents do not say how Ella will be covered, and our search of the FDA's 510(k) database found no record for it [R25].

The health economic study was expected in the first quarter of calendar 2026 and is now listed for the second half. It had not been released at 9 October 2026 [R15] [R1].

In screening, two trials of 202,638 and 78,216 women found no fall in deaths, and Cleo's stated minimum target is 99.6 per cent specificity. No results have been published for the screening test [R32] [R33] [R11].

THE SAMSO TAKE

A diagnostic company at this stage reminds me of an early-stage explorer. The early results tell you something is there. They do not tell you how well the test works in practice or whether it can be sold at a profit.

The next result matters more to me than anything published so far. The samples are collected, the formula gets fixed first, and an outside laboratory runs them.

I keep coming back to Aspira. It had the clearance, the code and the Medicare price, and after sixteen years it is still reporting losses. Cleo's kit model is different, and we do not know the kit price yet. So in my opinion an FDA clearance would be the first step, with payment still to come.

If the eight-marker test clears many more benign masses than the old tests did, does that change how laboratories and insurers behave? And will Cleo's cash last until they decide?

RELATED SAMSO COVERAGE

Samso has not written about Cleo before. In January 2026 Samso wrote about another ASX-listed company that is developing cancer blood tests, in BCAL Diagnostics expands early cancer detection.

VOCABULARY

The terms used in this piece

510(k)

The FDA route that clears a device by comparing it with one already on the market.

Adnexal mass

A lump or cyst on an ovary, a fallopian tube or the tissue next to them.

Algorithm

The formula that turns several measurements into one risk score.

Analytical validation

Testing of the kit itself, to show it gives the same reading from the same sample and is not thrown off by other substances or by storage.

Appendix 4C

The quarterly cash flow report some ASX companies must lodge.

Assay

A laboratory test.

Benign and malignant

Benign means not cancer. Malignant means cancer.

Biomarker

Something measurable in the body that signals a disease.

CA125

A blood protein that often rises with ovarian cancer and also with harmless conditions.

Cleared and approved

The FDA clears a device through the 510(k) route. Approval is a separate, longer process for higher-risk devices.

CLIA

The United States federal standard for laboratories that test patient samples.

Clinical validation

Testing that shows a kit gives the right answer in real patients.

Coverage decision

An insurer's decision that it will pay for a test.

CPT code

The five-character billing code attached to a medical service in the United States.

CXCL10

An immune signalling protein. Cleo's licensed biomarker.

De Novo

The FDA route for a new kind of device with no earlier equivalent.

False positive

A positive test result in a person who does not have the disease.

FDA

The United States Food and Drug Administration.

Going concern

A company that can keep operating. Accounts that state doubt about it are warning that the company may need new money to continue.

Gynaecological oncologist

A surgeon trained in cancers of the female reproductive organs.

HE4

A second blood protein used with CA125 in ovarian cancer tests.

Kit

The boxed set of materials a laboratory needs to run a test.

Laboratory-developed test

A test run only in the developer's laboratory. It does not need FDA clearance.

Medicare

The United States federal health insurance program, mainly for people aged 65 and over.

Negative predictive value

The share of negative test results that are truly clear.

Option

A right to buy a new share at a fixed price before a set date.

Payer

The insurer that pays for a medical service.

Pivotal trial

The study a regulator relies on to decide whether a product works.

Placement

A sale of new shares to chosen investors without an offer to all shareholders.

Positive predictive value

The share of positive test results that turn out to be cancer.

Predicate

The existing device a new device is compared with under the 510(k) route.

Prospective

A study that collects samples before the diagnosis is known. The samples may still be stored and tested later.

Reimbursement

Payment for a test by an insurer.

Research use only

A label for instruments and tests sold for laboratory research and not for testing patients.

Retrospective

A study that uses samples collected in the past, with the diagnosis already known.

RMI

The Risk of Malignancy Index, a score built from CA125, ultrasound and menopausal status.

ROMA

A cleared blood test that combines CA125 and HE4.

Screening

Testing people who have no symptoms.

Sensitivity

The share of people with a disease that a test correctly flags.

Specificity

The share of people without a disease that a test correctly clears.

Stage I

Ovarian cancer that is still confined to the ovary.

Triage

Sorting patients by risk so each is sent to the right care.

REFERENCES

References and sources

Every source below has an identifier. The same identifier appears in the text where the source is used. Figures labelled as company graphics, slides or photographs are reproduced from public Cleo documents with attribution. Figures labelled as original Samso illustrations chart published data and name the data. Share prices are as at the date at the front of this piece and move daily. Company figures are dated by the document they came from. Cleo documents were downloaded from the company's ASX announcements page on 9 October 2026.

[R1] Cleo Diagnostics Limited, "Appendix 4E and 2026 Annual Report", lodged with the ASX on 20 August 2026. cleodx.com/asx-announcements

[R2] Cleo Diagnostics Limited, "June 2026 Quarterly Activities Report" and Appendix 4C, lodged with the ASX on 29 July 2026. cleodx.com/asx-announcements

[R3] Cleo Diagnostics Limited, corporate presentation, "Pioneering the Transformation of Ovarian Cancer Detection", June 2025, slides 6, 8, 11, 14 and 21. cleodx.com

[R4] Cleo Diagnostics Limited, "CLEO Completes Biomarker Panel Optimisation Ahead of FDA 510(k) Submission", ASX release, 23 March 2026. cleodx.com/asx-announcements

[R5] Cleo Diagnostics Limited, "CLEO Reaches Key Milestone with Completion of Sample Collection for Pivotal U.S. Clinical Trial", ASX release, 31 March 2026. cleodx.com/asx-announcements

[R6] Cleo Diagnostics Limited, "CLEO Commences Kit Manufacturing Program Ahead of FDA Submission", ASX release, 28 April 2026. ASX document 06yxgfcmnz0b0x

[R7] Cleo Diagnostics Limited, "CLEO Establishes U.S. Reimbursement Pathway Ahead of FDA Submission", ASX release, 20 May 2026. cleodx.com/asx-announcements

[R8] Cleo Diagnostics Limited, "CLEO Enters Analytical Validation Phase", ASX release, 13 July 2026. ASX document 071n0py4pt0qqr

[R9] Cleo Diagnostics Limited, "CLEO Receives First Batch of Commercially Manufactured Test Kits", ASX release, 3 September 2026. ASX document 073nsj7mqgmxb1

[R10] Cleo Diagnostics Limited, "CLEO Selects CLIA Certified Laboratory for Pivotal U.S. Clinical Validation", ASX release, 10 September 2026. ASX document 073ybwq59m8cq8

[R11] Cleo Diagnostics Limited, "CLEO Commences Ovarian Cancer Screening Test Development", ASX release, 24 September 2026. cleodx.com/asx-announcements

[R12] Cleo Diagnostics Limited, "CLEO Files Patents for its Ovarian Cancer Screening Test", ASX release, 30 September 2026. cleodx.com/asx-announcements

[R13] Cleo Diagnostics Limited, "CLEO Raises $5m to Support U.S. Market Launch and Accelerate Screening Test Development", ASX release, 18 December 2025. ASX document 06th555qm9dyb2

[R14] Cleo Diagnostics Limited, Appendix 2A, application for quotation of securities, and notification of cessation of securities, both lodged with the ASX on 24 August 2026. ASX document 0734c0bxtl7p86

[R15] Cleo Diagnostics Limited, quarterly activities reports and Appendix 4C for the June 2025, September 2025, December 2025 and March 2026 quarters. cleodx.com/asx-announcements

[R16] Cleo Diagnostics Limited, "CLEO Confirms Next Generation Platform to Deliver its Ovarian Cancer Test", ASX release, 18 February 2026. ASX document 06wfpdbcd8rxgl

[R17] Cleo Diagnostics Limited, Notice of Annual General Meeting, lodged with the ASX on 17 September 2026. Meeting date 26 November 2026. cleodx.com/asx-announcements

[R18] ASX, admission notice for Cleo Diagnostics Limited, 18 August 2023. Quotation began 22 August 2023. ASX document 05ssk1myymfc8d

[R19] Stephens AN, Hobbs SJ, Kang SW, Bilandzic M, Rainczuk A, Oehler MK, Jobling TW, Plebanski M, Allman R. "A Novel Predictive Multi-Marker Test for the Pre-Surgical Identification of Ovarian Cancer". Cancers 15(21), 5267, 2 November 2023. DOI 10.3390/cancers15215267

[R20] Stephens AN, Hobbs SJ, Kang SW, Oehler MK, Jobling TW, Allman R. "Utility of a Multi-Marker Panel with Ultrasound for Enhanced Classification of Adnexal Mass". Cancers 16(11), 2048, 28 May 2024. DOI 10.3390/cancers16112048

[R21] ClinicalTrials.gov, record NCT06566716, "Validation of Ovarian Adnexal Mass Assessment Score Test System", sponsor Cleo Diagnostics Ltd, last updated 4 February 2025, read 9 October 2026. clinicaltrials.gov/study/NCT06566716

[R22] US Food and Drug Administration, decision summary for the OVA1 Test, K081754, De Novo DEN090004, decision 11 September 2009. FDA review K081754

[R23] US Food and Drug Administration, 510(k) decision summary for ROMA (HE4 EIA and ARCHITECT CA 125 II), K103358, decision 1 September 2011. FDA review K103358

[R24] US Food and Drug Administration, 510(k) decision summary for OVA1 Next Generation, K150588, decision 18 March 2016. FDA review K150588

[R25] US Food and Drug Administration, 510(k) and De Novo databases, records under product code ONX, including K151502, K153607 and K160090, read 9 October 2026 and searched again on 11 October 2026. FDA 510(k) database

[R26] US Food and Drug Administration, MDUFA performance report to Congress for financial year 2025, Table 5. FDA document 191127

[R27] US Food and Drug Administration, "Premarket Notification 510(k)" web page, and Code of Federal Regulations, Title 21, section 866.6050. fda.gov premarket notification 510(k)

[R28] Aspira Women's Health Inc, annual reports on Form 10-K for 2018 to 2025 and quarterly report on Form 10-Q for the June 2026 quarter, US Securities and Exchange Commission. SEC filing, Form 10-K for 2025

[R29] Centers for Medicare and Medicaid Services, Clinical Laboratory Fee Schedule, calendar year 2026, fourth quarter file, codes 81500, 81503 and 0003U. CMS file 26CLABQ4

[R30] Centers for Medicare and Medicaid Services, Medicare Claims Processing Manual, chapter 16, section 100.4. CMS manual, chapter 16

[R31] Bio-Techne Corporation, annual report on Form 10-K for the year to 30 June 2026, and press releases of 3 March 2021 (Asuragen), 16 February 2026 (Ella CE-IVD marking) and 23 September 2026 (shareholder approval). SEC filing, Form 10-K for 2026

[R32] Menon U and others. "Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial". The Lancet 397, 2182 to 2193, 2021. PubMed Central PMC8192829

[R33] Buys SS and others. "Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial". JAMA 305, 2295 to 2303, 2011. Abstract read. Europe PMC record 21642681

[R34] US Preventive Services Task Force, recommendation statement, "Screening for Ovarian Cancer", JAMA 319, 588 to 594, 2018, and topic page read 9 October 2026. uspreventiveservicestaskforce.org

[R35] US National Cancer Institute, SEER Cancer Stat Facts, Ovarian Cancer, read 9 October 2026. seer.cancer.gov/statfacts/html/ovary.html

[R36] US National Institutes of Health, consensus statement, "Ovarian Cancer: Screening, Treatment, and Follow-up", 1994. consensus.nih.gov

[R37] Earle CC and others. "Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients". Journal of the National Cancer Institute 98, 172 to 180, 2006. Abstract read. Europe PMC record 16449677

[R38] Manning B, Banerjee S, Hawkins TB and others. "Extracellular vesicle and particle-based blood test for ovarian cancer screening of average risk population: a promising nested case control study using preclinical samples". Gynecologic Oncology 203, 26 to 34, 2025. Abstract read. Europe PMC record 41135257

[R39] Bast RC and others. "Biomarkers and Strategies for Early Detection of Ovarian Cancer". Cancer Epidemiology, Biomarkers and Prevention 29(12), 2504 to 2512, 2020. PubMed Central PMC7710577

[R40] Yahoo Finance, daily closing prices for COV.AX, read 9 October 2026. finance.yahoo.com/quote/COV.AX

[R41] Davenport C and others. "Menopausal status, ultrasound and biomarker tests in combination for the diagnosis of ovarian cancer in symptomatic women". Cochrane Database of Systematic Reviews, 2022. Abstract read. DOI 10.1002/14651858.CD011964.pub2

[R42] Kang SW, Rainczuk A, Oehler MK, Jobling TW, Plebanski M, Stephens AN. "Active Ratio Test (ART) as a Novel Diagnostic for Ovarian Cancer". Diagnostics 11(6), 1048, 2021. DOI 10.3390/diagnostics11061048

[R43] INOVIQ Limited, ASX releases of 1 July 2026 and 30 September 2026 on the EXO-OC ovarian cancer test, Appendix 4C for the June 2026 quarter and Appendix 4E for the year to 30 June 2026. ASX announcements, IIQ

[R44] BCAL Diagnostics Limited, investor presentation, 6 October 2026, ASX release on Avantect Multi-Cancer, 23 September 2026, and Appendix 4C for the June 2026 quarter. ASX announcements, BDX

[R45] Dhar C, Ramachandran P, Xu G and others. "Diagnosing and staging epithelial ovarian cancer by serum glycoproteomic profiling". British Journal of Cancer 130(10), 1716 to 1724, 2024. Abstract read. ClinicalTrials.gov record NCT03837327. DOI 10.1038/s41416-024-02644-4

[R46] Law RA, Giles BM, Culp-Hill R and others. "Clinical Evaluation of a Multi-Omic Diagnostic Model for Early-Stage Ovarian Cancer Detection". Diagnostics 15(17), 2225, 2025. Written by AOA Dx authors. DOI 10.3390/diagnostics15172225

[R47] Mercy BioAnalytics, media release on FDA approval to start its pivotal ovarian screening study, 21 September 2026, and funding announcements of 3 April 2023 and 3 September 2025. mercybio.com

[R48] Rhythm Biosciences Limited, Appendix 4C for the June 2026 quarter, 30 July 2026. ASX announcements, RHY

[R49] ClearNote Health, media release on Series D financing, 27 May 2026, and media release on the billing code and Medicare payment rate for the Avantect ovarian test. clearnotehealth.com

[R50] US Food and Drug Administration, "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System", read 11 October 2026. FDA document 80370

[R51] AOA Dx, media release on enrolling the first participant in the APEX sample collection study, 5 May 2026. aoadx.com

[R52] Centers for Medicare and Medicaid Services, Transmittal 3881, Change Request 10232, 13 October 2017. CMS transmittal R3881CP

Cover photo: laboratory image from the cover of the Cleo Diagnostics Limited 2026 Annual Report, lodged with the ASX on 20 August 2026. Company image from a public ASX document. Cropped by Samso.

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