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Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the publication of an article on its triage test for ovarian cancer.
Highlights
- Results from the first clinical validation study of the CleoDX Triage Test, performed in a 334 patient cohort, have been published in the peer-reviewed journal “Cancers”
- The article, entitled ‘A novel predictive multi-marker test for the pre-surgical identification of ovarian cancer’ provides a detailed overview of the high performance of Cleo’s ovarian cancer diagnostics test
- The article concluded that Cleo’s ovarian cancer test:
- Was highly accurate with 95% sensitivity1 / 95% specificity2;
- Correctly discriminated malignant from benign samples; and
- Out-performed and was superior to current clinical methods.
- Peer-review provides important validation of Cleo’s technology and commercial strategy, targeting the surgical triage market where accurate and sensitive identification of malignant tumours is essential.
PEER REVIEWED PUBLICATION
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer- reviewed international journal ‘Cancers’. The results confirm the high accuracy of the CleoDX Triage Test, which was independent of menopausal status, and showed that it out-performed the two most widely used clinical scoring systems (the “Risk of Malignancy Index” and “Risk of Malignancy Algorithm”) for discriminating benign from malignant ovarian disease.
A copy of the publication is available here: https://www.mdpi.com/2072-6694/15/21/5267
Moreover, the CleoDX surgical triage test correctly identified 81% of early-stage cancer patients in the cohort.
Commenting on the publication, Cleo Chief Scientific Officer, Dr Andrew Stephens, said:
“These results confirm that our core technology is robust and accurate, and most importantly can identify cancers at an early stage. These results strongly support our planned further development of this core technology aimed at ovarian cancer screening in the longer term”.
CLEO Chief Executive, Richard Allman, added:
“This is an important step forward as we work towards our goal of an FDA approved triage test. I look forward to providing further updates to the market as we progress through our development program.”
The next step in development will confirm functionality of the commercially available kits in an independent clinical trial, the results of which will be submitted to the FDA for regulatory approval. Cleo anticipates commencement of this trial before the end of CY 2023.
OPPORTUNITY FOR CLEO AND OVARIAN CANCER DIAGNOSTICS MARKET
At present there is no clinically routine pre-surgical method for reliable evaluation and differentiation of benign vs malignant ovarian cancer tumours. Radical surgery is the cornerstone of cancer management, with complete hysterectomy being the norm. Removal of the ovaries, however, predisposes women to multiple co-morbidities including increased risk of cardiovascular disease, dementia and certain cancers amongst others. There is a clear need to differentiate benign vs malignant cases pre-surgically to enhance patient outcomes.
Cleo has defined a staged execution strategy to deliver it’s simple blood test which is focused on three key markets across pre-surgical triage testing, high-risk/recurrence detection, and broader screening programs. Achieving a positive outcome here from a peer-reviewed publication, has a material impact on the Company’s pathway with respect to the initial triage market. The Company will now use the publication of its test performance to further define the scope of the triage market.
Figure 1: Ovarian cancer diagnostic markets targeted by Cleo
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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.
COV:AU
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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This article includes content from HeraMED Limited, 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.
