Cleo Diagnostics
Cleo Diagnostics is an Australian molecular diagnostics company developing AdnexaSure™, a multi-marker blood test for early and accurate ovarian cancer detection, currently pursuing FDA 510(k) clearance for US launch via pathology laboratory and gynaecologic-oncology channels.
- Company typePublic
- Founded2021
- HeadquartersMelbourne, Australia
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Cleo Diagnostics does
Cleo Diagnostics Limited is an Australian molecular diagnostics company developing a portfolio of blood tests for the detection and management of ovarian cancer, with its core product being the CleoDX Pre-Surgical Triage Test branded AdnexaSure™. The test is a multi-marker immunoassay built on the CXCL10 biomarker — exclusively licensed worldwide from the Hudson Institute of Medical Research following 15+ years of academic research — combined with CA125, HE4, IL6 and additional markers, recently expanded from a 5-biomarker to an 8-biomarker panel. The assay is designed to run on Bio-Techne's Ella™ automated ELISA microfluidic platform, which delivers a 90-minute total run time and simultaneous measurement of multiple biomarkers per patient sample. The intended use is to distinguish benign from malignant ovarian/adnexal masses prior to surgery, addressing the documented failure of the current CA125-plus-ultrasound standard of care, which misses roughly half of early-stage cancers and generates substantial false-positive referrals.
The company has not yet generated commercial revenue and is pre-market, with US FDA 510(k) clearance being the gating commercial milestone. Its go-to-market motion is sales-led, targeting US gynaecologic oncologists, surgeons, and clinical pathology laboratories through standard blood-test ordering workflows, supported by Key Opinion Leader engagement (Dr Nicholas Lambrou appointed as the first US KOL in November 2025) and outsourced US market access via HcFocus. A lean operating model of 1-10 employees relies on partners for clinical trial execution (Lindus Health), biobank validation sample access (UCL/UKCTOCS and NCI/PLCO), antibody manufacturing scale-up (R&D Systems, a Bio-Techne subsidiary), health economics (EntityRisk), and payer intelligence (Norstella). Cleo is publicly listed on the ASX (ticker: COV) since 22 August 2023, headquartered at Level 2, 480 Collins Street, Melbourne, Australia, with no parent company and no controlling shareholder identified in the source material.
The product pipeline extends beyond pre-surgical triage to include ovarian cancer recurrence monitoring, a high-risk population test (BRCA mutation carriers and women with family history), and a long-term mass screening test, staged in increasing addressable market size and development risk. The first commercial product is positioned for a US pre-surgical triage addressable market of approximately 2.0 million women per year, identified via Norstella physician-and-claims data analysis. Capital structure as of late 2025 includes approximately A$5.75 million in cash (post A$1.7M R&D tax incentive refund and a A$5M December 2025 placement led by Petra Capital), with use of proceeds funding US commercial launch activities, reimbursement workstreams and screening-test development.
Cleo Diagnostics firmographics
Firmographics- Name
- Cleo Diagnostics
- Legal name
- Cleo Diagnostics Limited
- Website
- https://cleodx.com
- Company type
- Public
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Cleo Diagnostics is an Australian molecular diagnostics company developing AdnexaSure™, a multi-marker blood test for early and accurate ovarian cancer detection, currently pursuing FDA 510(k) clearance for US launch via pathology laboratory and gynaecologic-oncology channels.
- Ownership category
- akta.pro rank
Cleo Diagnostics industry classification
Industry- Product category
- Ovarian Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ)
Keywords
Where Cleo Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Melbourne
- HQ country
- Australia
- HQ region
- Oceania
Offices1 record
Markets served
Cleo Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Diagnostic Test Kits: Cleo's first commercial product (AdnexaSure™) is a blood test kit sold to pathology laboratories and ordered by physicians. Revenue is generated through sale of diagnostic test kits to clinical laboratories following regulatory approval. Pathology providers perform the test and return results to physicians. US market launch is planned following FDA 510(k) clearance.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
Cleo Diagnostics product offering
Product offeringCore offering
Cleo Diagnostics is developing and commercialising a proprietary blood-based diagnostic test (AdnexaSure™) for the early and accurate detection of ovarian cancer. The test uses the CXCL10 active ratio combined with additional biomarkers to generate a Risk of Malignancy score that distinguishes benign from malignant adnexal masses prior to surgery. The test is designed to be ordered and processed through standard clinical pathology laboratory workflows using the Bio-Techne Ella™ automated ELISA platform.
Product overview
Cleo Diagnostics is developing a portfolio of ovarian cancer blood tests based on its patented CXCL10 biomarker technology. The core product is the CleoDX Pre-Surgical Triage Test (AdnexaSure™), a CE-marked/FDA-cleared blood test that distinguishes benign from malignant ovarian masses prior to surgery. The technology platform uses a proprietary algorithm combining the CXCL10 active ratio with multiple biomarkers (CA125, HE4, IL6) to generate Risk of Malignancy scores. CLEO's staged execution strategy encompasses multiple test products: the initial pre-surgical triage market, followed by recurrence monitoring and high-risk population tests, ultimately leading to an early-stage screening test for general population detection.
Differentiator
Problem solved
Functional benefit
Brands
- AdnexaSure: CLEO's first test - AdnexaSure is designed to distinguish benign from malignant growths and will be compatible with standard diagnostic laboratory workflows worldwide.
Products and services
- AdnexaSure™ Pre-Surgical Triage Test A blood test (IVD kit) designed to accurately distinguish benign from malignant ovarian growths prior to surgical intervention. The test measures the CXCL10 active ratio combined with biomarkers including CA125, HE4, and IL6, processed on the Bio-Techne Ella™ automated ELISA platform, and returns a Risk of Malignancy score to the referring physician. It is intended for sale to clinical pathology laboratories and ordered by gynaecologists and oncologists.
Quantifiable outcome
- 90% early-stage (Stage I/II) cancer detection vs 50% with standard CA125+ultrasound workflows
- +5 more outcomes
Companies that use Cleo Diagnostics
Customer profileSegments3 records
Ideal customer profiles2 records
Cleo Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability2 records
Feature3 records
Cleo Diagnostics partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core, key and supporting.
- Bio-Techne Corporation (NASDAQ: TECH)coreCLEO selected Bio-Techne's Ella™ automated ELISA platform as the immunoassay instrument for its ovarian cancer blood test. The Ella™ platform uses microfluidic cartridges to measure CLEO's proprietary biomarker panel. Discussions are well progressed for a binding agreement for analytical validation. Both parties are aligned to enter a long-term manufacturing supply agreement following completion of validation activities. Bio-Techne generated over $1.2 billion in net sales in fiscal 2025.
- EntityRiskkeySpecialist in health economics and value modelling engaged to develop a model quantifying the economic benefits of adopting CLEO's Pre-Surgical Test for Ovarian Cancer in the US. The health economic analysis will provide evidence-based justification for payor engagement and reimbursement negotiations.
- Norstella (including MMIT)keyGlobal pharma intelligence solution provider engaged to examine detailed physician and claims data to identify high-value US launch markets and maximise early adoption potential. Norstella's market access and payer intelligence capabilities (including Managed Markets Insight & Technology/MMIT) inform reimbursement data modelling. Comprehensive analysis delivers refined TAM estimate and payer policy insights.
- National Cancer Institute (NCI) / PLCO Cancer Screening TrialcoreCLEO received formal approval from the US National Cancer Institute to access blood samples from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial biobank. The PLCO is considered a gold standard resource and one of the largest US longitudinal cancer studies. Samples will be used to generate data strengthening CLEO's FDA 510(k) submission and accelerate development of its screening test.
- University College London (UCL)coreCollaboration agreement with UCL granted CLEO access to over 2,000 blood samples from the UKCTOCS (United Kingdom Collaborative Trial of Ovarian Cancer Screening), the world's largest ovarian cancer screening trial. Data will be independently analysed in partnership with UCL, providing unbiased validation of CLEO's technology. Partnership with renowned Ovarian Cancer expert Professor Usha Menon supports both pre-surgical and screening market evaluation.
- R&D Systems, Inc. (subsidiary of Bio-Techne Corporation)coreR&D Systems, a global leader in immunoassay technology and subsidiary of Bio-Techne Group, was engaged to scale-up and assemble CLEO's proprietary antibodies for use in its initial Ovarian Cancer test targeted at the surgical triage market. The company undertook hybridoma cell line development, antibody production and testing, and reagent selection. This partnership represents the critical technology transfer step from in-house development to commercial-scale production.
- Siles HealthsupportingNetwork of 13 women's health and ultrasound specialist clinics across Melbourne and regional Victoria joined CLEO's Australian ovarian cancer trial, with Associate Professor Charles Siles as Principal Investigator. Partnership aims to provide insights into clinical workflows supporting market adoption and supplement the broader trial strategy.
- The Royal Women's Hospital MelbournesupportingAustralia's leading specialist hospital for women's health joined CLEO's ovarian cancer trial as a participating site, with Associate Professor Orla McNally (Director of Oncology and Dysplasia Service) as Principal Investigator. Partnership aims to broaden patient sampling, expand market awareness, verify and optimise the ovarian cancer blood test, and potentially bolster the US trial.
- Lindus HealthcoreUS-based Contract Research Organization (CRO) appointed to manage the successful execution of CLEO's ovarian cancer US clinical trials. Lindus Health was chosen for its proven experience, technology, and high standards in med-tech clinical trial management. The study targets up to 500 US patients with trial scheduled over 10 months. Lindus Health leverages innovative patient recruitment and trial management technology platform.
- HcFocus (New York)coreNew York-based strategic healthcare consultancy appointed to assist with US commercial activities. HcFocus specialises in helping med-tech companies access the US healthcare market, supporting FDA approval, reimbursement with private insurers, clinical trial support, KOL appointments, and industry/doctor engagement. Led by Dr Susan Gross (Ob/GYN), the team brings deep US healthcare industry experience and networks.
Scale indicators5 records
Recent moves7 records
Expansion highlights5 records
Cleo Diagnostics competitors and assessment
Company assessmentDirect peers
- Aspira Women's Health: Markets OVA1 and OVERA blood tests for pre-surgical triage of ovarian/adnexal masses — directly comparable to Cleo's AdnexaSure™ in the same indication, customer base (gynaecologists, pathologists) and clinical workflow.
- Natera: Provides oncology and reproductive-health blood-based diagnostics (Signatera, Empower, Vistara), overlapping with Cleo on biomarker-driven blood tests targeting women's health and oncology specialists.
Broad incumbents
- Myriad Genetics: Established hereditary and oncology diagnostics franchise (BRACAnalysis, MyChoice, Prolaris) sold through the same physician and pathology channels Cleo targets, providing both competitive pressure and a benchmark for women's-health oncology commercial models.
- Exact Sciences: Commercial leader in non-invasive cancer screening (Cologuard, Oncotype DX) with a broad oncology diagnostics portfolio and US sales infrastructure that could credibly extend into ovarian cancer screening if Cleo's platform proves out.
- Hologic: Large women's-health diagnostics and medical device company (ThinPrep, NovaSure, Panther molecular system) with established gynaecologist and pathology-lab relationships directly relevant to a pre-surgical ovarian triage launch.
- NeoGenomics: Oncology-focused clinical laboratory services business with broad oncologist and pathology-lab relationships; a potential commercial channel and indirect competitor in oncology diagnostics workflows.
Emerging players
- Guardant Health: Liquid-biopsy oncology testing franchise (Guardant360, Reveal) with overlapping biomarker-based blood-test technology and similar physician-channel go-to-market motion, though focused on genomic rather than proteomic signals.
- GRAIL: Multi-cancer early-detection blood test (Galleri) pursuing a population-screening indication that is the downstream commercial endpoint of Cleo's stated pipeline strategy.
- Freenome: Multiomics blood-based cancer screening developer with an overlapping biomarker-discovery and clinical-validation approach in oncology diagnostics.
Others
- Bio-Techne: Technology and manufacturing partner providing the Ella™ automated ELISA platform and antibody production services; not a competitor but a strategic dependency and enabling participant in Cleo's commercial pathway.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Cleo Diagnostics social profiles
Digital presenceCleo Diagnostics compliance and trust
Trust signalCompliance3 records
Cleo Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cleo Diagnostics leadership team
Management profileNumber of profiles
Profiles8 records
Cleo Diagnostics funding detail
Funding detailFunding overview
Funding rounds1 record
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cleo Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cleo Diagnostics
What does Cleo Diagnostics do?
Cleo Diagnostics is developing and commercialising a proprietary blood-based diagnostic test (AdnexaSure™) for the early and accurate detection of ovarian cancer. The test uses the CXCL10 active ratio combined with additional biomarkers to generate a Risk of Malignancy score that distinguishes benign from malignant adnexal masses prior to surgery. The test is designed to be ordered and processed through standard clinical pathology laboratory workflows using the Bio-Techne Ella™ automated ELISA platform.
Is Cleo Diagnostics a public or private company?
Cleo Diagnostics is a public company. It is classified as public and is currently operating.
When was Cleo Diagnostics founded?
Cleo Diagnostics was founded in 2021. It employs 1 to 10 people.
Where is Cleo Diagnostics based?
Cleo Diagnostics is headquartered in Melbourne, Australia, in the Oceania region.
How does Cleo Diagnostics make money?
One revenue line is on record: diagnostic Test Kits.
Who are Cleo Diagnostics's main competitors?
Direct peers on record are Aspira Women's Health and Natera. Broad incumbents are Myriad Genetics, Exact Sciences, Hologic and NeoGenomics. Emerging players are Guardant Health, GRAIL and Freenome. Bio-Techne is listed as an others.
Does Cleo Diagnostics have an API?
No public API is recorded for Cleo Diagnostics.
What industry is Cleo Diagnostics in?
Cleo Diagnostics's product category is Ovarian Cancer Diagnostics. Its primary akta.pro industry code is HLAAALAJ, Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening). Its NAICS code is 325413 and its SIC code is 2835.