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Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) confirms the delivery of early milestones in its development program targeting the initial surgical triage test market for its simple and accurate blood test.
Highlights
- Selection of biomarkers panel for Cleo’s ovarian cancer test-kit has been finalised
- Antibody development has advanced increasing confidence for commercial assay development and upscaling for commercial manufacturing
- The Company is in final stages evaluating four commercial antibody manufacturing partners
TEST-KIT BIOMARKERS PANEL FINALISED
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.
ANTIBODY DEVELOPMENT
A key objective for the Company is to develop its own antibodies and target proteins which will allow control of supply, quality, cost and high-performance of key reagents that will underpin the consistent and reliable manufacture of test-kits. Cleo can confirm that Surface Plasmon Resonance Analysis has shown that the core antibodies of the CXCL10 active ratio test are binding to their respective targets with high affinity and are suitable for commercial assay development and upscaling in commercial manufacturing. Hybridomas to produce the supporting biomarker antibodies are also well progressed, with expected completion of the full test-kit panel in Q2 CY2024.
Commenting on the early development progress, CLEO Chief Executive, Richard Allman, said:
“The commercial foundation for our ovarian cancer test-kit targeting the initial surgical triage market is coming together quickly. We are running a number of initiatives in parallel which are designed to place the Company in a strong position to achieve key milestones set this financial year.”
SELECTION PROCESS FOR ANTIBODY MANUFACTURING PARTNER
Cleo is in the late stages of evaluating four commercial antibody manufacturing partners as part of a robust tender process. The evaluation process considers a competitive review of the capabilities of each potential partner to ensure that the partner ultimately selected can deliver commercial product to the standard required by Cleo, which is largely set by regulatory bodies such as the Food and Drug Administration (FDA) and potential customer groups.
Figure 1: Indicative high-level timeline for the commercial development of Cleo’s ovarian cancer test-kit for the initial Surgical Triage Test market.
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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.
