Cleo Diagnostics Ltd
Cleo Diagnostics Limited is an ovarian cancer diagnostics company.
The business
Cleo Diagnostics Limited is an ovarian cancer diagnostics company. Its principal activities involve the development and patent of a blood test for the detection of ovarian cancer. It focuses on bringing to market a blood test for the early diagnosis of ovarian cancer based on the novel CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is absent in non-malignant disease. It is advancing the availability of its blood test, under a modular execution strategy, which is designed to address all ovarian cancer detection markets with specific tests, including surgical triage, recurrence, high risk, and early-stage screening. Triage Test is a pre-surgical test to determine ovarian or adnexal mass for which surgical referral is required who have not yet been referred to an oncologist.
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Latest news

Cleo Diagnostics Selects Bio-Techne’s US Laboratory for Pivotal Ovarian Cancer Test Validation
Cleo Diagnostics taps Bio-Techne's US lab for pivotal validation of its pre-surgical ovarian cancer test ahead of a 510(k) FDA filing in H1 2027.

Cleo Diagnostics to Commence Analytical Validation of Pre-Surgical Ovarian Cancer Blood Test
Cleo Diagnostics begins analytical validation of eight-biomarker pre-surgical ovarian cancer blood test after receiving 125 kits, advancing FDA submission.

Cleo Diagnostics Optimises Biomarker Panel for Ovarian Cancer Blood Test Ahead of FDA Submission
Cleo Diagnostics expands ovarian cancer blood test biomarker panel to eight ahead of FDA submission, boosting robustness and paving US market entry (ASX: COV).

Cleo Diagnostics Selects Next-Generation Ella Platform to Deliver Ovarian Cancer Blood Test
Cleo Diagnostics (ASX:COV) selects Bio-Techne's Ella ELISA platform to run its ovarian cancer test, advancing toward FDA 510(k) filing and supply deal.
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