Cleodx

Ovarian Cancer detection starts here:
CLEO Diagnostics is making early diagnosis of ovarian cancer a reality with a simple and accurate blood test.

[Cleodx @Cleodiagnostics]

$COV to present this week at @VEvents_RIU Gold Coast Investment Showcase Event.

Event details:
When:  Thursday, 11 June 2026
Time:  11.15am AEST
Where:  In-person - JW Marriott Gold Coast Resort & Spa, QLD.

Register to attend: https://t.co/FKAbY6pqi2

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth @jaxoncrabb ASX.COV #invest

[Cleodx @Cleodiagnostics]

CLEO Establishes U.S. Reimbursement Pathway Ahead of FDA Submission

▪�� CLEO to enter U.S. market under miscellaneous CPT code 81599 immediately post-FDA clearance, enabling early billing and real-world utilisation data capture

▪ Reimbursement determined via cross-walking to comparable multi-biomarker tests, which have reported reimbursement levels of ~US$500-US$900 per test, supporting CLEO’s initial pricing discussions

▪ Represents the first step toward securing a dedicated CPT code, supporting long-term reimbursement and commercial scale.

Link to release: https://t.co/BeFgJP8uhp

#CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

Cleo Diagnostics Quarterly Activities Report March 2026.

Link to release: https://t.co/dakyKwC3HN

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth #invest ASX.COV

[Cleodx @Cleodiagnostics]

$COV.ax Commences Kit #Manufacturing Program
ahead of #FDA Submission.

▪️Initial phase of staged manufacturing program now underway with @biotechne to support production of CLEO’s test kits
▪ Follows completion of sample collection for CLEO’s pivotal #U.S. #clinicaltrial, marking transition to analytical validation and clinical sample testing
▪ Staged approach designed to reduce technical and manufacturing risk ahead of full-scale test kit production and FDA 510(k) submission.

Link to release: https://t.co/JeXIAFt0hi

#CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV.ax reaches Key Milestone with Completion of
Sample Collection for Pivotal U.S. Clinical Trial.

▪️514 blood #samples collected for CLEO’s #clinicaltrial, representing a key step toward the Company’s #FDA submission for its Pre-Surgical #OvarianCancer Test

▪ 624 women enrolled across 19 U.S. sites, demonstrating strong trial execution supporting a robust final study dataset

▪ Binding manufacturing agreement for test kit production remains in the final stages following recent #biomarker panel optimisation

▪ Achieving sample target moves CLEO into final execution phase comprising pre-verification, analytical validation, sample testing, clinical data analysis & validation.

Link to release: https://t.co/r8AMVqwmYz

#CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV.ax Completes #Biomarker Panel #Optimisation Ahead of FDA 510(k) Submission.

▪️Biomarker panel expanded from five to eight biomarkers, improving analytical robustness, reproducibility and commercial manufacturability.

▪ Optimised panel has been designed for high #throughput Ella™ platform, supporting scalable global deployment without compromising #performance.

▪ Binding #manufacturing agreement imminent, with partner aligned and experienced in development and production of the selected biomarkers.

▪ Test kit production to support #FDA analytical validation activities to commence immediately following execution.

Link to release: https://t.co/7gujXuzXYg

#CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV.ax Confirms Next Generation Platform to Deliver its Ovarian Cancer Test.

▪️Bio-Techne’s Ella™ selected, a next-generation automated #ELISA platform, as the #immunoassay instrument for CLEO's #ovariancancer blood test.

▪️@biotechne (NASDAQ: TECH) is a global developer, manufacturer and supplier of high-quality reagents, analytical instruments and immunoassay technologies.

▪️The Ella™ platform can deliver materially improved assay sensitivity, precision and automation compared with conventional ELISA platforms.

▪️Binding agreement discussions well progressed with Bio-Techne for analytical validation to enable sample testing and clinical trial completion.

▪️Both parties aligned to enter long-term manufacturing supply agreement following completion of these activities.

Link to release: https://t.co/PazP8G9zBJ

#CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

February is Ovarian Cancer Awareness Month.

Ovarian cancer is often called the “silent cancer” — not because it has no symptoms, but because the symptoms are vague, common, and frequently overlooked.

At Cleo Diagnostics, we’re working to change that with our simple blood test for earlier, more accurate detection.

Awareness matters. Earlier answers matter.

#OCAM #CleoDX $COV.ax #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV End of Year Letter to Shareholders.

Link to release: https://t.co/csqa0mfieZ

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV raises $5M to support U.S. market launch
and accelerate screening test development.

▪ $5 million raised through a well-supported placement at $0.60 per share

▪ Funds will be used to support U.S. market entry and commercial launch of Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test

▪ Placement introduces highly credentialed institutional and high net worth investors to the register, alongside support from existing shareholders.

Link to release: https://t.co/fq21LHwQAx

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV strengthens cash position with ~$1.7m R&D Tax incentive refund.

CLEO now holds a strong cash balance of ~$5.75 million as at 25th November 2025, meaning the Company remains well funded to execute on its key near-term milestones, including the completion of its U.S. pivotal clinical trial and FDA submission next year for its Pre-Surgical Ovarian Cancer Test.

Link to release: https://t.co/CFYRAsGxaW

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV appoints its first U.S. Key Opinion Leader, Dr Nicholas Lambrou, a leading gynaecologic oncologist and surgical specialist.

▪ Dr Lambrou to support clinical advocacy, publication development, and presentation of CLEO’s technology at major U.S. scientific meetings
▪ KOL engagement represents a key U.S. market entry activity as a part of CLEO’s commercialisation strategy for its Pre Surgical Ovarian Cancer Test.

Link to release: https://t.co/JhbwZ4a1mZ

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

Reminder: $COV to present today at @VEvents_RIU TechKnow Invest Webinar Event. Register below to view.

Event details:
When:  Tuesday, 18 November 2025
Time:  from 12pm AEDT
Where:  Virtual
Register: https://t.co/lP7Kzllih6

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth @chapter1advisor @David_TaskerIR @jaxoncrabb ASX.COV #invest

[Cleodx @Cleodiagnostics]

article: @SmallCapsASX
CLEO Diagnostics Expands US Addressable Market for Pre-Surgical Ovarian Cancer Test

https://t.co/97mAteyahp

[Cleodx @Cleodiagnostics]

article: @StockheadAU
Health Check: It’s all the way in the USA as ASX medtechs ramp up in Trumpland

https://t.co/PMXprwcbnq

[Cleodx @Cleodiagnostics]

$COV significantly expands U.S. addressable market for its pre-surgical #ovariancancer test.

▪ Updated U.S. insurance data identifies over ~2 million women per year could benefit from CLEO’s Pre-Surgical Ovarian Cancer Test

▪ Findings reinforce the unmet need and significant commercial potential for CLEO’s patented technology

▪ Data will inform a broader health economic study to support CLEO’s market entry, reimbursement and early revenue generation.

Link to release: https://t.co/wOrnwHc5Gc

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

Reminder: $COV to present today at JMM Sydney Opera House Virtual Event.

Event details:
When:  Tuesday, 28 October 2025
Time:  10.50 AEDT  (event commences 10.00am)
Where:  Virtual - register at https://t.co/ybgWSVKCeF

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest

[Cleodx @Cleodiagnostics]

$COV Chief Scientific Officer, Dr Andrew Stephens & Head of Corporate Development, Dayna Louca, will present at the @JMM_Australia Sydney Opera House Investor Event this week.

Investors can still register to attend the follow up virtual event on Tuesday, 28 October 👉 Register here - https://t.co/Qrx2ZsfNea

Cleo Diagnostics (ASX:COV) is transforming ovarian cancer detection with it accurate and simple blood test.

Ovarian cancer is often diagnosed late, resulting in an alarming 5-year survival rate of just 49%, compared to #breastcancer which has a 92% 5-year survival rate - highlighting the urgent need for earlier detection.

For more information, go to https://t.co/ZXtFjtIhWT or email us at [email protected]

#CleoDX #ovariancancer #ovarian #cancer #medtech #womenshealth ASX.COV #invest