- 01Cleo test beat screening targets in 247-patient PoC.
- 02High-risk: 92.2%/98.7%; general population: 75%/100% sensitivity/specificity.
- 03Independent validation next.
Cleo Diagnostics (ASX: COV) has confirmed that its prototype ovarian cancer screening test has met and exceeded a set of pre-defined performance thresholds in its first proof-of-concept (PoC) study on patients with varied stages of the disease.
The first-stage retrospective study—performed on 247 women comprising 87 healthy individuals, 67 women with benign gynaecological disease, and 93 with ovarian cancer—included 62 cases of early (Stage I) ovarian cancer where diagnosis has the greatest survival benefit.
Cleo set minimum performance benchmarks informed by best practice for high-risk population screening (minimum 90% sensitivity and 90% specificity, targeting women with hereditary or genetic factors that predispose them to ovarian cancer development), and general population screening (minimum 75% sensitivity and 99.6% specificity, targeting asymptomatic women within the broader population).
The study achieved a high-risk screening result of 92.2% sensitivity and 98.7% specificity, and a general population result of 75% sensitivity and 100% specificity.
It was also reported to have outperformed the gold standard CA125 with area under the curve clinical calculation of 0.99 for Stage I and 0.98 for all-stage cancers.
Population Screening
Chief 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 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.
“Triage remains our near-term priority with our path to market with screening being the larger long-term opportunity and this encouraging result is the first step towards that.”
Next-Stage Testing
Next-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 (UKCTOCS), as well as a large-scale prostate, lung, colorectal, and ovarian cancer screening trial sponsored by the the US National Cancer Institute.
UKCTOCS is the world’s largest randomised controlled trial evaluating whether population-based screening can reduce deaths from ovarian and tubal cancer.
“Detecting ovarian cancer at its earliest stages remains one of the greatest unmet needs in women’s healthcare, and our next step will be about scale and statistical power, followed by evaluation in a real world screening population,” Dr Allman added.
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