CLEO meets with US FDA to develop strategy for ovarian cancer test launch

Ovarian cancer diagnostics company Cleo Diagnostics (ASX: COV) has taken a major step towards the US launch of its pre-surgical triage test for ovarian cancer detection. The Company wrapped up an initial pre-submission meeting with the U.S. Food and Drug Administration (FDA), thus setting its regulatory journey in motion.

Ovarian cancer is a serious health concern, with about 1,815 Australians diagnosed each year and around 1,000 lives lost annually. Despite these alarming statistics, there is currently no reliable early detection test for ovarian cancer, as traditional methods like pap smears do not identify the disease.

That’s where CLEO comes in. During the FDA meeting, it outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre-submission meeting is designed to permit CLEO to receive early guidance from FDA review teams prior to an eventual application submission. 

Cleo Diagnostics is focused on developing a blood test based on the CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in non-malignant conditions. A recent study by Cleo demonstrated that its test outperforms current clinical workflows, correctly detecting 90% of early-stage cancers compared to just 50% with existing methods using Cancer Antigen 125 (CA125) and ultrasound. It also noted that the test can be easily adapted for use in clinical practice. 

In Q3 FY24, as part of its US market access strategy, Cleo engaged New York-based industry partner HcFocus to assist with its reimbursement program. At the end of the quarter, the Company had $9.973M cash in the bank, with a cash burn of $1.2 million year-to-date.

The meeting with the FDA was interactive. The administration provided constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the US for its ovarian cancer detection blood test. 

Early interaction with the FDA is important as part of CLEO’s US market access strategy for many reasons. The guidance outcomes allow CLEO to refine its clinical trial design to maximise resourcing and data quality, reduce the possibility of rework, shorten the potential timeframe for application submission, and operate with an open and transparent approach. 

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product, the pre-surgical Triage test, via the 510(k) application pathway. This approach provides the quickest pathway to regulatory approval for devices that achieve “substantial equivalence” to an existing predicate.

CLEO’s clinical trial design has now been reviewed and approved in the US and Australia. Institutional Review Board (IRB) (an independent ethics committee) approval is a legal requirement for any clinical trial to ensure that trial activities are ethically sound and compliant with federal regulations. Trial sites are being formally contracted, and patient recruitment will commence shortly. 

CLEO is working with Lindus Health, a U.S.-based Contract Research Organisation (CRO), to manage the trial’s international arm. 

As of 2022, the US had the third-highest ovarian cancer rates. With its patented blood test, CLEO is trying to position itself for success in the lucrative market.