{"url":"https://newsforagent.com/news/2026-10-21/cleo-diagnostics-ovarian-cancer-test-targets","markdown_url":"https://newsforagent.com/news/2026-10-21/cleo-diagnostics-ovarian-cancer-test-targets.md","title":"Cleo Diagnostics Test Tops Targets in 247-Woman Study","headline":"Cleo Diagnostics Ovarian Cancer Test Beats Screening Benchmarks in First Proof-of-Concept Study","description":"Cleo Diagnostics' prototype ovarian cancer test hit 92.2% sensitivity in a 247-woman study, clearing pre-set screening thresholds ahead of larger cohort testing.","section":"Research & Clinical Trials","published_at":"2026-10-21T01:04:08+00:00","modified_at":"2026-10-21T01:04:08+00:00","author":"News Desk","key_takeaways":["Cleo Diagnostics' prototype ovarian cancer screening test achieved 92.2% sensitivity and 98.7% specificity for high-risk screening in a 247-woman study.","The study included 62 Stage I ovarian cancer cases and reported an area under the curve of 0.99 for Stage I disease.","Next-stage testing will run on a larger independent cohort, with samples already collected from UKCTOCS and a US National Cancer Institute screening trial."],"companies":[{"name":"Cleo Diagnostics","is_primary":true,"profile_url":"https://akta.pro/company-profiles/0009jvs/cleo-diagnostics","website":"https://www.cleodx.com"}],"source":{"publisher":"TradingView","title":"Cleo Diagnostics Exceeds Performance Targets in First PoC Study of Ovarian Cancer Screening Test","url":"https://www.tradingview.com/news/smallcaps:af3fe0eee094b:0-cleo-diagnostics-exceeds-performance-targets-in-first-poc-study-of-ovarian-cancer-screening-test/"},"other_sources":[],"tags":["Research & Clinical Trials","Cleo Diagnostics"],"body_markdown":"[Cleo Diagnostics](https://akta.pro/company-profiles/0009jvs/cleo-diagnostics) said its prototype ovarian cancer screening test met and exceeded pre-defined performance thresholds in a first proof-of-concept study of 247 women, achieving 92.2% sensitivity and 98.7% specificity for high-risk screening. The Australian company [reported](https://www.tradingview.com/news/smallcaps:af3fe0eee094b:0-cleo-diagnostics-exceeds-performance-targets-in-first-poc-study-of-ovarian-cancer-screening-test/) the results on October 21, 2026.\n\n## How the 247-Woman Study Was Run\n\nThe first-stage retrospective study covered 87 healthy individuals, 67 women with benign gynaecological disease and 93 with ovarian cancer, including 62 cases of early Stage I disease. Cleo set minimum benchmarks of 90% sensitivity and 90% specificity for high-risk population screening, and 75% sensitivity and 99.6% specificity for general population screening.\n\nThe study returned 75% sensitivity and 100% specificity for general population screening. It also outperformed the gold standard CA125 with an area under the curve of 0.99 for Stage I and 0.98 for all-stage cancers.\n\nChief executive officer Dr Richard Allman said the results offered the first evidence that Cleo's biomarkers may have utility in population screening beyond its lead pre-surgical ovarian cancer test, which is scheduled for US regulatory submission in the new year. \"We set a demanding target before we began precisely so that clearing it would provide meaningful progress,\" he said. \"Meeting and exceeding those benchmarks for high-risk and general population screening with a single assay gives us confidence that the underlying biology and panel design are sound.\"\n\n## Cleo Diagnostics' Path to a US Submission\n\nCleo Diagnostics is an Australian molecular diagnostics company developing AdnexaSure, a multi-marker blood test for early ovarian cancer detection, and is pursuing FDA 510(k) clearance for US launch, according to akta.pro [company records](https://akta.pro/company-data). The same records show the company completed pivotal US clinical trial sample collection in March 2026 with 514 eligible blood samples from 624 enrolled women across 19 US sites, satisfying the trial's 500-patient minimum. Cleo expanded its biomarker panel from five to eight biomarkers that month, and in February 2026 selected Bio-Techne's Ella automated ELISA microfluidic platform as the commercial immunoassay instrument for the test.\n\n## Testing That Led to the Screening Study\n\nIn September 2026, Cleo Diagnostics said it would begin analytical validation of its pre-surgical ovarian cancer blood test after receiving the first production batch of 125 kits from Bio-Techne, TradingView reported. The company reported a 31.6% decline in revenue to $232,352 and a 48.4% increase in net loss to $5.9 million for its 2026 financial year, according to Tipranks. In August 2026, AInvest reported that 8.45 million listed options expired unexercised on August 22, removing approximately 6% of potential dilution from its share base.\n\n## What Comes Next for the Screening Test\n\nNext-stage testing will be conducted on a larger independent cohort to confirm initial performance estimates, improve statistical power, assess reproducibility across broader patient populations, and establish that sample collection, processing and storage conditions do not affect assay performance. Samples for real world screening applications have already been collected from cohorts within the UK collaborative trial of ovarian cancer screening and a large-scale prostate, lung, colorectal, and ovarian cancer screening trial sponsored by the US National Cancer Institute.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}