Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has received a cash refund of $1,716,580 from the Australian Government for its FY25 Research and Development (R&D) Tax Incentive claim.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce the appointment of leading U.S. gynaecologic oncologist, Dr Nicholas Lambrou, as the Company’s first Key Opinion Leader (KOL).

MELBOURNE, AUSTRALIA, 6th November 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has established a significantly larger Total Addressable Market (TAM) for the United States (U.S.) with respect to its Pre-Surgical Ovarian Cancer Test.

Cleo’s Chief Scientific Officer Dr Andrew Stephens and Head of Corporate Development Dayna Louca recently spoke at the JMM Opera House Investor Lunch on how their breakthrough CXCL10 biomarker platform could address one of medicine’s toughest challenges, the early detection of ovarian cancer.

Watch the Q&A with Head of Corporate Development Dayna Louca.

Article by TechInvest

Cleo Diagnostics (ASX: COV) has reached a major regulatory milestone, announcing the successful completion of Stage One of the Medical Device Single Audit Program, or MDSAP. This marks a significant step toward global market access for its pre-surgical ovarian cancer diagnostic test.

MELBOURNE, AUSTRALIA, 15th September 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (FDA) at its second pre-submission meeting for the Company’s first commercial product, being its Ovarian Cancer Pre-Surgical Triage Test.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce it has engaged and commenced work with EntityRisk and Norstella to deliver a United States (U.S.) focused health economic analysis and market assessment for its first commercial product, the Ovarian Cancer Pre-Surgical Test.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce it has received formal approval from the U.S. National Cancer Institute (NCI) to access blood samples held within the globally respected Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial biobank. This represents a significant milestone that supports the Company’s planned FDA 510(k) submission for its Ovarian Cancer Pre-Surgical Test.

CLEO’s Chief Executive Officer, Richard Allman and Chief Scientific Officer, Andrew Stephens, provide an update on the Company’s progress and commercialisation pathway.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce the successful completion of alpha testing for its Ovarian Cancer pre-surgical triage test kit, marking a critical step along its manufacturing pathway towards commercial production.

Cleo Diagnostics Chief Scientific Officer, Dr Andrew Stephens, joins Andrew Geoghegan of ausbiz to discuss the importance of the partnership with the University College London to access 2000 UKCTOCS biobank samples.

Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has entered into a Collaboration Agreement with University College London (UCL) to access over 2,000 samples from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), the world's largest Ovarian Cancer screening trial.

CLEO is pleased to announce the commencement of technology transfer activities supporting the development of its simple blood test for the early and accurate detection of Ovarian Cancer. This marks the completion of a critical milestone in the manufacturing pathway for CLEO to deliver its commercially available, FDA-compliant diagnostic test kit.

CLEO has expanded its ovarian cancer Australian trial to include Siles Health network of 13 clinics across Melbourne and regional Victoria. Siles Health is a prominent women’s health and ultrasound specialist, with Associate Professor Charles Siles, acting as Principal Investigator.

CLEO has expanded its ovarian cancer Australian trial with the inclusion of the Royal Women’s Hospital as a participating site.

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

Cleo Diagnostics Limited (ASX:COV) is pleased to announce progress for its U.S. clinical trials in support of its FDA application for its ovarian cancer diagnostic blood test.

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to provide the market with an update on activities in the June 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress in its regulatory strategy for its first commercial product, the pre-surgical triage test.

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce the publication of a milestone article on its blood test for the accurate and early detection of ovarian cancer.