CLEO Diagnostics (ASX: COV) has used an analysis of insurance data to significantly expand the total addressable market in the US for its new pre-surgical ovarian cancer detection test.
The company commissioned global pharma intelligence solution provider Norstella to reassess its initial patient market in preparation for its US entry next year.
CLEO expects the findings to inform a broader health economic study in support of the company’s reimbursement and early revenue generation efforts.
Insurance Claim Analysis
Norstella based its analysis on open insurance claim data across commercial, Medicaid, and Medicare channels—representing the majority of the US population—to capture a near real-time snapshot of healthcare utilisation.
The comprehensive and detailed dataset enabled Norstella to identify that up to 3.4 million US women each year present with a suspected ovarian or adnexal mass—either malignant, benign, or indeterminate.
Of this group, around 2 million women per year proceed to further diagnostic investigation through radiological imaging or biomarker testing, which aligns with current pre-surgical triage practice.
Total Addressable Market
The analysis defined CLEO’s total addressable market and immediate commercial opportunity for the pre-surgical ovarian cancer blood test to measure the patented and novel CXCL10 biomarker produced at high levels in all stages of malignant ovarian cancer, but not in benign versions of the disease.
The broader population of 3.4 million US women represents an extended cohort that could also benefit from the technology.
CLEO believes that increasing industry recognition of the accuracy, clinical utility, and cost-efficiency of its test will drive uptake beyond the initial addressable market.
Commercial Opportunity
Norstella’s findings indicated a materially larger and more accessible commercial opportunity than CLEO had previously estimated.
It also highlighted geographical areas of high patient volume, allowing the company to strategically target and optimise its US launch strategy.
The findings did not capture the recurrence or asymptomatic population screening markets, which are thought to be substantially larger.
The analysis will underpin a broader health economic study conducted in partnership with EntityRisk and Norstella to quantify the clinical and economic value of the pre-surgical ovarian cancer test in real-world healthcare settings.
Building Value in Cancer Detection
CLEO chief executive officer Dr Richard Allman said the company intends to progressively expand its addressable market and build value across all tiers of the ovarian cancer detection cycle.
“Ovarian cancer has the highest mortality rate of all female gynaecological cancers and being able to establish a much larger US patient market for our early detection test is an amazing opportunity,” he said.
“The findings of this analysis expand the evidence base needed to progress into detailed health economic modelling which will be central to our US reimbursement strategy, ensuring we are positioned for successful market entry and adoption.”
