Cleo Diagnostics

September 2023 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the September 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.


  • U.S.patent granted for key novel ovarian cancer biomarker supporting CLEO's commercialisation pathway into its primary U.S. target market
  • Early progress delivered against development program with the selection of biomarkers panel for Cleo’s ovarian cancer test-kit finalised
  • Antibody development advanced increasing confidence for commercial assay development and upscaling for commercial manufacturing
  • Evaluation of four commercial antibody manufacturing partners progressed in late stage as part of a robust tender process
  • Board capacity enhanced with Chief Scientific Officer and Executive Director, Dr Andrew Stephens, expanding responsibilities to full-time
  • A$10.73M cash at bank at 30 September 2023

The granted Patent (U.S. Patent No: US 11,725,048, "CXCL10 Binding Proteins and Compositions Thereof”) covers CLEO proprietary biomarkers and antibody formulations, which comprise the core technology of the Company’s ovarian cancer diagnostic blood test. This Patent family is directed towards C-X-C motif chemokine ligand 10 (CXCL10) binding proteins and methods of diagnosing a condition, such as a malignancy, comprising determining a level of CXCL10 in a subject. Determination of the level of CXCL10 may also be utilised to monitor tumour burden, malignancy progression or likelihood of tumour recurrence in a subject.

The U.S. Patent expands the Company’s Intellectual Property (IP) portfolio, adding to the patent granted in Australia earlier this year (patent number 2020404453). Additional patent applications are currently pending in Europe, China, India, Japan, Korea, Israel, New Zealand and Singapore.


The U.S. is the largest diagnostic market in the world, and represents the Company’s primary target market for its potentially lifesaving simple diagnostic blood test. Ovarian cancer survival rates are much lower than other cancers that affect women, largely due to the fact that existing testing is insufficient to identify early stage cancers or differentiate from benign disease. Diagnosis is only made following radical surgery to remove the ovaries. The 5 year survival rate for ovarian cancer is 49%, compared to 92% for breast cancer1 where early detection screening exists.

A significant unmet clinical need exists and CLEO plans to bring to market a suite of ovarian cancer diagnostic blood tests based on the novel patented CXCL10 biomarker, which is expressed early and at high levels by ovarian cancers, but not in non-malignant disease. The tests aim to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by pathology laboratories worldwide.

The U.S. Patent complements CLEO’s regulatory approval strategy designed to access target markets and secure a path to reimbursement approvals in the future. The Company is also currently preparing for the submission of a 510(k) U.S. Food and Drug Administration (FDA) application.

CLEO is initially targeting the delivery of its blood test for the surgical triage market, however has a staged execution strategy that de-risks a pathway to all ovarian cancer diagnostic markets:

  • Surgical Triage Distinguishes benign from malignant disease to allow appropriate design of treatment before surgical intervention is considered;
  • Recurrence Identifies relapse for earlier intervention to control/manage disease progression
  • High Risk Screening Testing women with known BRCA status or extensive family history; and
  • Early Stage Screening Systematic national screening to identify early stage ovarian cancers in patients without symptoms, to allow medical intervention before cancer spreads.

Early detection is vital. When ovarian cancers are diagnosed at stage 1, patients have over a 90% 5 year survival rate. However, this rate reduces rapidly to <40% if diagnosed once the cancer has spread beyond the ovaries.


Cleo has finalised the selection of biomarkers to be used in its ovarian cancer test-kit, along with completing the development for a prototype of the proprietary scoring algorithm. The performance metrics of the test were evaluated in a clinical study of 334 patients, the results of which are being prepared for publication in a peer-reviewed medical journal. The Company expects the publication outcome to be reported to the market by the end of CY2023. The data cannot be released prior to publication due to the nature of the peer-review process. Concurrently, Cleo is also preparing a further patent application based on the findings.

Click here for the full ASX Release

This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects


The Conversation (0)
Cleo Diagnostics (ASX:COV)

Cleo Diagnostics

Keep reading...Show less

Medtronic LABS: Opening Up Software To Expand Access to Healthcare


Medtronic LABS makes its digital health platform open source

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and Flagship Pioneering, the bioplatform innovation company, today announced the formation of a strategic partnership to develop and commercially scale multiproduct platforms on an accelerated basis.

Through this collaboration, Thermo Fisher and Flagship will work together to create new platform companies focusing on novel tools and capabilities that seek to power the biotech ecosystem and accelerate the development of first-in-class therapies. The newly formed strategic partnership is an expansion of the long-standing supply relationship between Thermo Fisher and Flagship, which extends to Flagship's ecosystem of companies and leverages the expertise of both organizations including the areas of life science tools, diagnostics, and services.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic reports second quarter fiscal 2024 financial results

Solid execution results in mid-single digit revenue growth, driven by broad-based strength across multiple businesses and geographies; Major innovative product approvals; Raises fiscal year guidance

Medtronic plc (NYSE:MDT) today announced financial results for its second quarter of fiscal year 2024 (FY24), which ended October 27, 2023 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic announces FDA approval of minimally invasive device to treat hypertension

The Symplicity blood pressure procedure offers patients a new adjunct approach to lowering blood pressure

Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral ™ renal denervation (RDN) system, also known as the Symplicity ™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.

Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low. These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.

"Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension."

The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.

"The Symplicity blood pressure procedure is safe and effective, providing significant 'always on' blood pressure reductions for patients," said David Kandzari , M.D., chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study."

Patient preference and shared decision making have been identified as critical components of developing a hypertension care plan including the Symplicity blood pressure procedure. According to results from a Medtronic-led patient preference study, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one third of patients were likely to choose the interventional treatment.

"This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes," said Raymond Townsend , M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program. "The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down."

The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN and is backed by experience in more than 25,000 patients treated globally, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk. Although currently limited for investigational use in Japan , China and Canada , the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit , and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.


Krystin Hayward Leong

Ryan Weispfenning

Public Relations

Investor Relations



(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia:

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Ocumetics Technology

Ocumetics Announces Private Placement

Ocumetics Technology Corp. (“ Ocumetics ” or the “ Corporation ”) ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) announces that it proposes to complete a non-brokered private placement of up to 3,125,000 units of the Corporation (“ Units ”) at a price of $0.32 per Unit for gross proceeds of up to $1,000,000. There will be no minimum subscription level for this offering. Each Unit will consist of one common share in the share capital of the Corporation (“ Common Share ”) and one-half of one common share purchase warrant. Each whole warrant (“ Warrant ”) will entitle the holder to purchase one additional Common Share at an exercise price of $0.64 for a period of two years from the date of issuance of the Warrant.

Keep reading...Show less

Medtronic: A Majority of Americans Are Optimistic That AI Will Improve Healthcare in 2024

According to a new survey from Medtronic and Morning Consult, respondents recognize potential of AI to enable earlier diagnosis and improve access to care

Medtronic More than half (51%) of U.S. adults are optimistic new applications of artificial intelligence (AI) will lead to major advancements and breakthroughs in healthcare in the year ahead, according to a new survey from Medtronic, a global healthcare technology leader, and Morning Consult

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects


Latest Press Releases

Related News