Sightful Invest
  • Business
  • Investing
  • Politics
  • Stock
Top Posts
Former FBI Director Robert Mueller has Parkinson’s disease:...
Earthwise Advertising & Investor Awareness Campaign
Commencement of Henbury Field Program
RCM to Acquire Webbs Consol Silver Project from...
Basin Energy
Epstein estate to hand over ‘birthday book’ to...
Dyan Cannon denied White House entry after lying...
Israel eliminates Houthi prime minister in Yemen airstrike...
Sen. Bernie Sanders calls on RFK Jr. to...
Trump appointee exits US foreign aid agency after...
  • Business
  • Investing
  • Politics
  • Stock

Sightful Invest

Investing

Cleo Commences U.S. Clinical Trials

by admin September 6, 2024
September 6, 2024
Cleo Commences U.S. Clinical Trials

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to confirm the commencement of U.S. clinical trials for its ovarian cancer diagnostic blood test.

Highlights

U.S. clinical trials commenced with first patients enrolled over 8 recruitment centresTrial will validate the use of CLEO’s ovarian cancer blood test for the U.S. marketPathway set toward FDA submission in CY2025.

Commencement of U.S. Clinical Trials

CLEO’s pivotal FDA-enabling clinical trial has commenced in the United States, with first patients recruited into the study. The trial is designed to benchmark CLEO’s technology, with recruitment targeting a minimum of 500 patients with diversity representative of the U.S. population. The data collected will underpin a submission to the Food and Drug Administration (FDA) seeking approval for clinical use of CLEO’s ovarian cancer detection blood test in the world’s largest diagnostic market.

Eight participating medical institutions, located across 6 U.S. states, are currently recruiting patients. Eligible patients at these sites will be identified by their primary physician and given the opportunity to participate during their consultation. Additional sites may also be included as the trial progresses.

Commenting on the commencement of U.S. clinical trials, CLEO Chief Executive, Richard Allman, said:

“Commencement of our U.S. trials confirm a significant milestone for CLEO and sets a clear pathway now for our planned entry into the U.S. market.

We have already demonstrated that CLEO’s ovarian cancer blood test is highly accurate, can detect early-stage cancer, and importantly is significantly better than clinical tools used today. This gives us confidence in moving through the trial activities to enable our FDA submission.

It is important to note that no diagnostic test exists today for ovarian cancer. Diagnosis can only be made after surgery. The opportunity in front of us is immense and CLEO is well positioned and funded to achieve access into our initial pre-surgery test market.”

Click here for the full ASX Release

This post appeared first on investingnews.com

previous post
Arcadium Halts Mount Cattlin Expansion, Plans Transition to Care and Maintenance
next post
Experts warn Iran could have a nuclear bomb before the next president takes office

You may also like

SSR Mining’s Marigold Mine Reaches Production Milestone of...

January 3, 2025

Precious Metals & Critical Minerals Hybrid Investor Conference...

May 18, 2025

Chris Vermeulen: Gold Short-term Price Target, Plus Key...

January 29, 2025

Presenting on Emerging Growth Conference 81 Day 1...

April 15, 2025

Charbone Hydrogen Announces Closing of Units for Debt...

June 3, 2025

Quimbaya Gold: Unlocking High-grade Gold Potential in Antioquia,...

January 18, 2025

Potash Fertilizers: What’s the Difference Between SOP and...

January 24, 2025

Allied Critical Metals Closes First Tranche of Oversubscribed...

August 15, 2025

Bitcoin Well Completes Full Lightning Network Integration to...

September 5, 2024

CHARBONE Hydrogen Provides Update on Flagship Sorel-Tracy Project,...

August 14, 2025

Recent Posts

  • Former FBI Director Robert Mueller has Parkinson’s disease: report
  • Earthwise Advertising & Investor Awareness Campaign
  • Commencement of Henbury Field Program
  • RCM to Acquire Webbs Consol Silver Project from Lode Res.
  • Basin Energy

    Become a VIP member by signing up for our newsletter. Enjoy exclusive content, early access to sales, and special offers just for you! As a VIP, you'll receive personalized updates, loyalty rewards, and invitations to private events. Elevate your experience and join our exclusive community today!


    By opting in you agree to receive emails from us and our affiliates. Your information is secure and your privacy is protected.

    Categories

    • Business (902)
    • Investing (2,872)
    • Politics (3,525)
    • Stock (4)
    • About us
    • Privacy Policy
    • Terms & Conditions

    Disclaimer: sightfulinvest.com, its managers, its employees, and assigns (collectively “The Company”) do not make any guarantee or warranty about what is advertised above. Information provided by this website is for research purposes only and should not be considered as personalized financial advice. The Company is not affiliated with, nor does it receive compensation from, any specific security. The Company is not registered or licensed by any governing body in any jurisdiction to give investing advice or provide investment recommendation. Any investments recommended here should be taken into consideration only after consulting with your investment advisor and after reviewing the prospectus or financial statements of the company.

    Copyright © 2024 Sightful Invest. All Rights Reserved.