Sightful Invest
  • Business
  • Investing
  • Politics
  • Stock
Top Posts
Top 5 moments from Charlie Kirk’s memorial service...
Trump set to approve TikTok deal ensuring majority-American...
Harris is speaking. This time, she isn’t bending...
Hamas letter to Trump asks for 60-day ceasefire...
Trump must make UN funding conditional on real...
Democrats skip Charlie Kirk Arizona memorial after 58...
‘Due to overhelming support:’ Turning Point USA says...
Thune slams Democrats’ ‘cold-blooded partisan’ tactics as funding...
Macron stakes anti-Trump global role with Gaza initiative...
Trump assassination attempt suspect Ryan Routh questions first...
  • 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

Binding Commitments Received for A$1.0 Million under Convertible...

April 28, 2025

Crypto Market Update: Ethereum Rallies Past US$4,000, Trump...

August 9, 2025

Excellent Gold Intersections Verified at Kiimala Project

May 12, 2025

Successful $30m placement supports production growth in 2025

December 9, 2024

Fertilizers: The Difference Between Potash and Phosphate (Updated...

November 14, 2024

Outstanding Drill Results Confirm High Grade Uranium Mineralisation...

September 28, 2024

Crypto Market Recap: Bitcoin Hits All-Time High as...

July 12, 2025

Stardust Power Announces Year End 2024 Financial Results

March 28, 2025

Anteros Secures Knob Lake Property Mineral Tenure to...

February 5, 2025

Shallow, high-grade gold in Sandstone drilling

April 10, 2025

Recent Posts

  • Top 5 moments from Charlie Kirk’s memorial service in Arizona
  • Trump set to approve TikTok deal ensuring majority-American investor control: White House
  • Harris is speaking. This time, she isn’t bending to Biden’s bullies
  • Hamas letter to Trump asks for 60-day ceasefire deal to release half of hostages, sources say
  • Trump must make UN funding conditional on real reforms, ex-diplomat urges

    Sign up for our newsletter to receive the latest insights, updates, and exclusive content straight to your inbox! Whether it's industry news, expert advice, or inspiring stories, we bring you valuable information that you won't find anywhere else. Stay connected with us!


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

    Categories

    • Business (927)
    • Investing (3,032)
    • Politics (3,709)
    • Stock (4)
    • About us
    • Contact 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 © 2025 Sightful Invest. All Rights Reserved.