Cleo Diagnostics Limited (ASX:COV), an ovarian cancer diagnostics company aiming to bring to market a simple blood test for the early diagnosis of ovarian cancer, has announced it received approval to access blood samples from the Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial biobank. This biobank, managed by the U.S. National Cancer Institute (NCI), is considered a ‘gold standard resource’ for cancer studies. Cleo Diagnostics will use these samples to bolster its FDA 510(k) submission for its Pre-Surgical Test and accelerate the development of its Screening Test.
The company’s Chief Executive Officer, Dr. Richard Allman, stated that securing access to the PLCO biobank is a major milestone and validates the scientific merit of Cleo’s technology. Data from the PLCO cohort is expected to significantly strengthen the clinical evidence supporting the FDA submission. The company recently announced a partnership with University College London to access the UKCTOCS biobank, adding to its comprehensive clinical evidence.
The studies using the PLCO biobank will evaluate Cleo’s Pre-Surgical Test’s ability to distinguish between benign and malignant adnexal masses. Furthermore, studies will assess Cleo’s technology to improve diagnostic lead time using longitudinal samples collected prior to diagnosis in an asymptomatic population. Cleo’s technology has previously demonstrated 95% sensitivity and 95% specificity in distinguishing malignant from benign adnexal masses.
In addition to this development, Cleo Diagnostics’ U.S. clinical trials are ongoing, with completion anticipated in Q4 CY2025. The company is currently focused on recruiting patients from high-volume metropolitan surgical centres. Access to the PLCO biobank and continued progress in clinical trials support Cleo Diagnostics’ strategy to enhance early detection and improve outcomes in ovarian cancer.
