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Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early. Cleo is well-positioned to leverage this market opportunity considering a compelling addressable market for this technology.
Developed over the course of a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for the purposes of screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
The CleoDX Technology is readily accessible powered with an AI-based risk assessment feature that leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
This Cleo Diagnostics profile is part of a paid investor education campaign.*
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COV:AU
Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
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Revolutionising Ovarian Cancer Diagnosis Through Accurate and Early Detection
HeraMED Signs Strategic Collaboration Agreement with Garmin Health
- HeraMED has executed a collaboration agreement with Garmin;
- Agreement enables integration of Garmin smartwatch data through the Garmin Health API into HeraMED’s clinical grade remote monitoring pregnancy platform, HeraCARE;
- Expansion of the range of health data available to expectant mothers and their healthcare providers;
- HeraMED and Garmin will jointly collaborate on marketing efforts to promote their integrated solutions;
- Collaboration includes exploration of women's health research opportunities
Driven by Garmin Health, a leading provider of digital health solutions that leverage the data and insights of the Garmin product ecosystem, the collaboration will focus on data integration, joint marketing initiatives and exploration of women’s health research. Using the Garmin Health API, pregnant women who consent to sharing their health and fitness activity data through the Garmin Health API can wear Garmin smartwatches and have their health data collected and integrated into the HeraCARE platform, including:
- Expanded health metrics including heart rate, sleep patterns, and fitness activity levels
- Improved continuous monitoring capabilities for pregnant women
- Enhanced data quality and quantity for more informed decision-making
The collaboration will allow HeraCARE users to seamlessly connect their Garmin devices, providing a more comprehensive view of maternal health. This integration is expected to significantly augment the platform's existing capabilities, which include fetal and maternal heart rate monitoring, blood pressure tracking, and mood assessment. This collaboration will have an initial 3-year term with either group having the ability to withdraw by providing 3 months notice.
HeraMED Managing Director and CEO, Anoushka Gungadin, commented: “This is an incredibly exciting collaboration for HeraMED. Garmin is a globally recognised brand that has developed a specific smartwatch technology strategy for women. It is a significant step forward in our mission to revolutionise maternity care. By incorporating Garmin's high-quality sensor data into HeraCARE, we're expanding and enhancing our ability to provide continuous, real-time health insights to expectant mothers and their healthcare providers.
We are delighted to bring health and wellness data into our clinical grade platform for the purpose of transforming the model of care for maternity. The additional data points will contribute to HeraMED’s ‘data- as-an-asset’ approach with the possibility to monitor activities such as steps for pregnant mothers with hypertensive or diabetic conditions or sleep quality for our mental health care plans will only enrich the capability of HeraCARE.”
Garmin Health Senior Director of Global B2B Sales Joern Watzke said: “We are excited to collaborate with HeraMED to leverage Garmin smartwatch technology in support of women’s healthcare. This strategic relationship will highlight how Garmin wearable data can extend beyond informing daily healthy habits to supporting pregnancy monitoring by providing healthcare providers with valuable patient insights. By making smartwatch technology and advanced health data available for a variety of applications in the fields of healthcare, insurance and research, we believe Garmin is truly helping change the future of women’s healthcare for the better.”
In addition to the HeraCARE platform integration, HeraMED and Garmin will explore potential research collaborations and data integrations through the Garmin Health API focused on women’s health, including maternity care. This collaboration is dedicated to research and data rather than commercial and it is intended will develop specific research projects to be supported by targeted granting bodies in key target markets.
This collaboration agreement does not involve any direct financial consideration between the companies. However, HMD anticipates the collaboration is beneficial as it will enhance the HeraCARE platform by providing a more holistic view of maternal health by bringing health and wellness data together, and the additional data points will contribute to HMD's ‘data-as-an-asset’ strategy.
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