Cleo Diagnostics to Commence Analytical Validation of Pre-Surgical Ovarian Cancer Blood Test

Cleo Diagnostics (ASX: COV) is set to commence analytical validation (AV) of its pre-surgical ovarian cancer blood test following receipt of the first production batch of 125 commercial test kits manufactured by US-based Bio-Techne.

Delivery of the batch, which follows the completion of the assay development and optimisation activities required to translate Cleo’s technology into a commercial test format, represents a significant milestone in the company’s regulatory program.

The batch will be subject to standard internal quality control and documentation procedures ahead of the two-week AV process to demonstrate that the recently upgraded eight-biomarker assay performs reliably and reproducibly from an analytical perspective.

The inclusion of three new biomarkers on top of the original five is designed to reduce the test’s reliance on any single analyte and mitigate variabilities often observed in early-stage assay production, serving to significantly strengthen assay reproducibility and reduce technical risk.

Ovarian cancer involving malignant tumours has a low cure rate and, despite treatment, over 70% of patients will develop recurrence of the disease within three years.

FDA Submission Support

Cleo chief executive officer Richard Allman said receipt of the first batch test kits would significantly advance the development program.

“It means we are almost ready to begin generating the formal regulatory data to support our planned US [Food and Drug Administration] submission, and represents the culmination of significant work undertaken to translate our technology into a reproducible commercial assay,” he said.

“With our prospective clinical samples already collected and the first commercial test kits now undergoing validation, we are entering an important period of execution as we progress towards clinical results, FDA submission, and ultimately commercialisation.”

Two additional production batches will be subject to the same AV tests to prove that performance can be reproduced consistently across separate manufacturing runs.

Evaluation across all three batches is expected to provide important evidence of assay robustness and manufacturing consistency and demonstrate that Cleo’s test can deliver consistent analytical performance.

Clinical Validation to Follow

The AV process will be followed by clinical validation (CV), which evaluates the test’s clinical performance on Cleo’s targeted female population, and will include analysis of prospective blood samples collected through a pivotal US clinical trial, together with samples from healthy individuals and patients presenting with relevant confounding conditions.

Cleo in currently in final negotiations with a certified laboratory to conduct the CV testing program, with successful validation expected to generate a critical component of the regulatory evidence required to support an FDA 510(k) submission during the FY27.

The company is developing a simple blood test for the accurate and early diagnosis of ovarian cancer based on the novel and patented CXCL10 biomarker, which is produced early and at high levels by malignant ovarian cancers but is largely absent in benign forms of the disease.

The test aims to distinguish benign from malignant growths in a standard format designed to be readily compatible with equipment used by diagnostic laboratories worldwide.

Currently, the five-year survival rate after an ovarian cancer diagnosis is 49%, with expensive treatment involving invasive surgery and intensive chemotherapy.