CLEO Strengthens FDA Submission Following Access to Globally Respected U.S. Biobank
Highlights
CLEO granted approval from U.S. National Cancer Institute to access blood samples
from the Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening TrialPLCO biobank considered a ‘gold standard resource’ and is one of the largest and
most influential U.S. longitudinal cancer studies conducted to dateCLEO will use samples from PLCO biobank to:
– Generate data to strengthen its FDA 510(k) submission for the Pre-Surgical Test
– Accelerate development and commercialisation of its Screening TestRecruitment for U.S. clinical trials ongoing with completion anticipated Q4 CY2025.
MELBOURNE, AUSTRALIA, 25th June 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO or the Company) is pleased to announce it has received formal approval from the U.S. National Cancer Institute (NCI) to access blood samples held within the globally respected Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial biobank. This represents a significant milestone that supports the Company’s planned FDA 510(k) submission for its Ovarian Cancer Pre-Surgical Test.
Commenting on access to the PLCO biobank, Chief Executive Officer, Dr Richard Allman, said:
“Securing access to the PLCO biobank is a major milestone for CLEO, and another strong endorsement of the scientific merit behind our technology. The PLCO is a highly respected U.S.-based cancer screening study, and inclusion of data from this cohort will significantly strengthen the clinical evidence package supporting CLEO’s FDA 510(k) submission.
Importantly, we are driving our commercial strategy forward which includes partnering with one of the world’s largest biobanks. This adds to our recently announced partnership with University College London to access the UKCTOCS biobank. Together, these biobanks form a comprehensive, internationally representative intended-use population that CLEO will use to enhance the totality of its clinical evidence and substantially de-risk key regulatory milestones. Ultimately, this will help to fast-track our Screening Test development.”