Cleo Diagnostics

March 2024 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 March 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.


Highlights

  • Design transfer activities completed, with reliable and reproducible data supporting progression to prototype manufacture
  • Publication of second peer-reviewed dataset confirms substantial performance advantage over current standard of care testing using CA125
  • CLEO’s strategic U.S. market access and reimbursement program underway with appointment of New York-based industry partner HcFocus
  • U.S. clinical trial established, with U.S.-based Lindus Health managing site logistics and patient recruitment
  • Physician engagement commenced in Australia
  • A$9.973M cash at bank at 31 March 2024.

2nd PEER REVIEWED PUBLICATION

The article, entitled ‘Reclassification of patients with ambiguous CA125 for optimised pre-surgical triage’ was published in the peer reviewed medical journal, Diagnostics.

A copy of the publication is available here: https://www.mdpi.com/2075-4418/14/7/671 The article concluded:

a) CLEO’s test correctly identified most cancer cases missed by CA125, including a majority of patients with early stage cancers;

b) The test provided superior identification of benign disease to eliminate the majority of "false positive" results obtained using CA125; and

c) The test efficiently discriminated malignant from benign samples.

Background

Further data for CLEO’s ovarian cancer triage test has been published in the peer-reviewed international journal ‘Diagnostics’.

Whilst these clinical studies are complex documents to interpret for the lay-reader, they form an integral part of Cleo’s commercialisation strategy. They are crucial for providing documentary evidence of Cleo’s test performance and will be used:

  • To support Cleo’s case to be included in national and international medical guidelines;
  • To support Cleo’s applications for private insurance coverage in the USA; and
  • To inform clinicians of Cleo’s test performance to drive uptake.

The latest study assessed the use of CLEO’s triage test to rescue those cases where CA125 provided an incorrect indication. Accurately identifying cancer patients early is critical to provide immediate referral to a gynaecological oncology specialist for surgery; whilst allowing better management of patients with non-malignant disease.

The study compared the potential clinical benefit to patients if CLEO’s Test was used for initial diagnostic work-up instead of CA125, the current gold standard ovarian cancer biomarker.


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.

COV:AU
Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
Cleo Diagnostics

Cleo Diagnostics


Keep reading...Show less
The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

Cleo Diagnostics (COV:AU) has announced The Royal Women's Hospital Joins CLEO Ovarian Cancer Trial

Download the PDF here.

Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge

By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic

When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential

FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic reports second quarter fiscal 2025 financial results

Delivering on commitments, executing ahead of expectations, and raising guidance

Innovation driving sustained growth across many franchises:  TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

Cleo Diagnostics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×