OncoAssure
OncoAssure Ltd is a Dublin-based molecular diagnostics company developing and commercializing prognostic biomarker tests for cancer. Its lead product, OncoAssure Prostate, uses a six-gene RT-qPCR assay combined with the CAPRA clinical score to guide prostate cancer treatment decisions for urologists.
- Company typePrivate
- Founded2021
- HeadquartersDublin, Ireland
- Headcount11–50
- GTM typeB2B
- OfferingServices
What OncoAssure does
OncoAssure Ltd is an Irish molecular diagnostics company that develops and commercializes prognostic biomarker tests for cancer management, with a primary focus on prostate cancer. The company was co-founded in March 2021 by Des O'Leary (CEO) and Professor William Gallagher (CSO) as a spin-out from OncoMark Ltd following Cepheid's acquisition of OncoMark and its OncoMasTR breast cancer test. OncoAssure serves urologists, urologic oncologists, and prostate cancer specialists who manage the roughly 70% of localized prostate cancer patients with slow-growing disease suitable for surveillance and the 30% with aggressive disease requiring treatment, addressing the over-treatment problem with personalized prognostic information.
The company's lead product is OncoAssure Prostate, an RT-qPCR-based in vitro diagnostic that measures expression of a six-gene panel comprising four prognostic 'master driver' genes and two reference genes, combined with the CAPRA clinical risk score to generate a Molecular Clinical Risk Score (MCRS). The test is validated for two decision points — post-biopsy and post-prostatectomy — and has demonstrated externally validated AUC of 0.83 (MCRS) versus 0.76 (CAPRA) and 0.69 (EAU) in a 203-patient Swedish UPCA cohort, with clinical validation across more than 600 samples in Irish and Swedish populations. Pipeline products applying the same master driver methodology include prognostic tests for cutaneous melanoma, bladder cancer, oesophageal cancer, and squamous cell carcinoma. Published evidence appears in European Urology Focus and BJUI Compass, with presentations at AUA, ASCO GU, and ESMO.
OncoAssure's business model relies on a Laboratory Developed Test (LDT) distribution structure through CAP/CLIA-certified laboratory partners rather than a kit-based model. In the US, the test was launched commercially in April 2025 via DiaCarta's CAP/CLIA laboratory in Pleasanton, California, and scaled nationally in May 2026 through an exclusive partnership with GoPath Diagnostics (Illinois), which provides national urology sales infrastructure. Revenue flows to OncoAssure through licensing and partnership arrangements with these laboratory providers; pricing is not publicly disclosed. The company also enables in-house hospital testing on standard RT-qPCR instruments. Founded with European academic and translational support (UCD, Lund University, Enterprise Ireland), OncoAssure is headquartered at NovaUCD in Dublin, Ireland, employs 11-50 staff, and is privately held.
OncoAssure firmographics
Firmographics- Name
- OncoAssure
- Legal name
- OncoAssure Ltd
- Website
- https://oncoassure.com
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- OncoAssure Ltd is a Dublin-based molecular diagnostics company developing and commercializing prognostic biomarker tests for cancer. Its lead product, OncoAssure Prostate, uses a six-gene RT-qPCR assay combined with the CAPRA clinical score to guide prostate cancer treatment decisions for urologists.
- Ownership category
- akta.pro rank
OncoAssure industry classification
Industry- Product category
- Molecular Cancer Diagnostics
- NAICS
- Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF)
- akta.pro secondary industries
- Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Molecular Pathology & Tissue Biomarkers (IHC/ISH, digital pathology-linked markers) (HLAAAMAI), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
Keywords
Where OncoAssure is headquartered
LocationHeadquarters
- HQ city
- Dublin
- HQ country
- Ireland
- HQ region
- Europe
Offices1 record
Markets served
OncoAssure business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D
Revenue model
- Laboratory Diagnostic Testing Services: OncoAssure's prostate cancer prognostic test is provided as a CAP/CLIA certified laboratory service. The company partners with CLIA-certified laboratory operators (DiaCarta in California, GoPath Diagnostics in Illinois) who perform the testing and bill for the service. Revenue flows to OncoAssure through its distribution and partnership agreements with these laboratory providers rather than directly from end customers.
- Licensing and Commercialization Partnerships: OncoAssure licenses its prostate cancer test technology to laboratory partners for commercialization. The company was also developing a strategic collaboration with DiaCarta for Laboratory Developed Test (LDT) validation and CMS reimbursement coding. The 2026 partnership with GoPath grants exclusive US distribution rights, representing a commercialization licensing model.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
OncoAssure product offering
Product offeringCore offering
OncoAssure develops and commercialises molecular prognostic biomarker tests for cancer management, with its lead product being OncoAssure Prostate — a six-gene RT-qPCR expression assay that combines master driver gene expression data with the CAPRA clinical risk score to generate a Molecular Clinical Risk Score (MCRS) for prostate cancer prognosis. The test is offered as a Laboratory Developed Test (LDT) through certified CAP/CLIA laboratory partners in the United States, guiding urologists on treatment decisions at both post-biopsy and post-surgery decision points.
Product overview
OncoAssure is a medical diagnostics company that commercializes a portfolio of molecular prognostic tests for cancer management. The core product is OncoAssure Prostate, a clinically validated six-gene expression assay that assesses risk of aggressive prostate cancer and biochemical recurrence to guide treatment decisions between active surveillance and intervention. The company previously developed the OncoMasTR breast cancer test (acquired by Cepheid in 2021). OncoAssure's development pipeline includes prognostic tests for cutaneous melanoma, bladder cancer, oesophageal cancer, and squamous cell carcinoma. Tests are developed using the OncoAssure Process, which identifies master driver genes and creates RT-qPCR-based in vitro diagnostic assays designed to run on standard laboratory equipment.
Differentiator
Problem solved
Functional benefit
Products and services
- OncoAssure Prostate A next-generation six-gene molecular prognostic test that predicts risk of aggressive prostate cancer post-biopsy and biochemical recurrence post-surgery. The test combines master driver gene expression analysis with the CAPRA clinical risk score to generate a Molecular Clinical Risk Score (MCRS), guiding urologists in treatment decisions between active surveillance and intervention for men diagnosed with localized prostate cancer.
Quantifiable outcome
- 20-29% reduction in unnecessary interventions when using OncoAssure Prostate to guide treatment decisions
- +4 more outcomes
Companies that use OncoAssure
Customer profileSegments2 records
Ideal customer profiles2 records
OncoAssure technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature4 records
OncoAssure partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- GoPath DiagnosticscoreOncoAssure entered an exclusive partnership with Illinois-based GoPath Diagnostics in May 2026, granting GoPath exclusive rights to provide the OncoAssure Prostate test throughout the United States. GoPath is a CAP-accredited and CLIA-certified anatomic, molecular, and digital pathology company. The partnership leverages GoPath's national sales infrastructure in urology to expand access to validated prognostic testing. GoPath will provide the test to urologists across the US market, complementing its existing portfolio of prostate cancer diagnostics including morphologic and molecular diagnosis, targeted immunotherapies, and germline testing. The agreement was announced publicly on May 11, 2026.
- Icahn School of Medicine at Mount SinaicoreOncoAssure signed a research collaboration agreement with the Icahn School of Medicine at Mount Sinai in New York in January 2026. The study is led by Dr. Ash Tewari, a world-renowned urologist and prostate cancer specialist, in collaboration with basic and translational cancer researchers Sujit S. Nair and Dimple Chakravarty. The study analyses prostate biopsy tissue from men with low- to intermediate-risk prostate cancer to assess the prognostic value of OncoAssure Prostate and evaluate its added value beyond routinely used clinical and pathological information. The collaboration aims to generate high-quality evidence supporting the test's role in patient management.
- DiaCarta Inc.coreOncoAssure entered a strategic collaboration with DiaCarta in February 2024 to commercialise its prostate cancer prognostic test. The collaboration focused on completing Laboratory Developed Test (LDT) validation for the OncoAssure prostate test in DiaCarta's CAP/CLIA laboratory in Pleasanton, California, and obtaining CMS coding, billing, and reimbursement. DiaCarta is a pioneer in molecular diagnostic test development for cancer and infectious diseases, with expertise in customisable clinical diagnostic services. The test was subsequently launched in the US market at AUA 2025 via DiaCarta's ISO and CAP/CLIA certified laboratory service.
- University College Dublin (UCD)coreOncoAssure was co-founded in 2021 based on research conducted at UCD. The company maintains ongoing collaborations with researchers from UCD's Conway Institute and School of Biomolecular and Biomedical Science. Clinical validation studies for OncoAssure Prostate involved researchers from UCD along with Lund University, Sweden. Professor William Gallagher serves as Professor of Cancer Biology at UCD and Deputy Director of Precision Oncology Ireland.
- Lund University, SwedencoreLund University in Sweden collaborated on the development and clinical validation of the OncoAssure Prostate test, including the external validation study involving the Swedish Urology Prostate Cancer (UPCA) cohort of 203 patients. Professor Anders Bjartell, a prominent urologist at Lund University, was involved in the research collaboration. The Swedish Cancer Society and Swedish Scientific Council provided funding support for the studies.
- DiaCarta Inc. (LDT Validation and Reimbursement)minorBeyond the strategic collaboration for commercialization, DiaCarta was engaged to facilitate completion of Laboratory Developed Test (LDT) validation and to handle applications to the Centers for Medicare & Medicaid Services (CMS) for coding, billing, and reimbursement for the OncoAssure prostate test.
Scale indicators8 records
Recent moves7 records
Expansion highlights5 records
OncoAssure competitors and assessment
Company assessmentEmerging players
- Bio-Techne: Bio-Techne acquired Exosome Diagnostics, which offers prostate cancer exosome-based prognostic tests; an emerging precision oncology diagnostics peer overlapping with OncoAssure on molecular prognostic testing for urological cancers.
- Strata Oncology: Strata Oncology provides tumor molecular profiling and prognostic insights for solid tumors; overlaps with OncoAssure's biomarker-based prognostic approach for urological and other cancers, though broader in scope.
- miR Scientific: miR Scientific develops the Prostate Cancer Screening (PCSx) urine-based test for prostate cancer; an earlier-stage emerging competitor focused specifically on prostate cancer diagnostics like OncoAssure.
Direct peers
- MDxHealth: MDxHealth offers SelectMDx and ConfirmMDx, prostate cancer diagnostic and prognostic tests sold to the same urologist customer base; competes directly with OncoAssure Prostate for urology mind-share and reimbursement budget.
- Veracyte: Veracyte owns Decipher Biosciences, whose Decipher Prostate genomic classifier is the leading commercial prognostic test for prostate cancer; directly competes with OncoAssure Prostate in the same urology channel serving the same risk stratification use case post-biopsy and post-prostatectomy.
- Exact Sciences: Exact Sciences offers the Oncotype DX Genomic Prostate Score (GPS), an established gene-expression prognostic test for low-to-intermediate risk prostate cancer patients directly competing with OncoAssure Prostate on biopsy-based treatment planning.
- Myriad Genetics: Myriad markets Prolaris, a gene-expression prognostic test for prostate cancer that directly competes with OncoAssure Prostate on biopsy-based and post-surgical risk assessment for urologist decision-making.
Broad incumbents
- QIAGEN: QIAGEN is a global leader in molecular diagnostics including prostate cancer prognostic content; provides sample technologies and assays that overlap with OncoAssure Prostate's broader category in urology diagnostics.
- Cepheid: Cepheid acquired OncoMark (OncoMasTR breast cancer test, the predecessor technology to OncoAssure Prostate) in March 2021 and commercializes a suite of oncologic molecular diagnostics on the GeneXpert platform; broader diagnostics incumbent with potential strategic interest in OncoAssure's pipeline.
- Hologic: Hologic is a larger molecular diagnostics company with cancer and women's health franchises; overlaps with OncoAssure in the broader molecular diagnostics space and could be an emerging acquirer of precision oncology prognostic content.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
OncoAssure social profiles
Digital presenceOncoAssure compliance and trust
Trust signalCompliance2 records
OncoAssure financial estimates
Financial estimateRevenue estimate
Valuation estimate
OncoAssure leadership team
Management profileNumber of profiles
Profiles2 records
OncoAssure funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
OncoAssure 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 OncoAssure
What does OncoAssure do?
OncoAssure develops and commercialises molecular prognostic biomarker tests for cancer management, with its lead product being OncoAssure Prostate — a six-gene RT-qPCR expression assay that combines master driver gene expression data with the CAPRA clinical risk score to generate a Molecular Clinical Risk Score (MCRS) for prostate cancer prognosis. The test is offered as a Laboratory Developed Test (LDT) through certified CAP/CLIA laboratory partners in the United States, guiding urologists on treatment decisions at both post-biopsy and post-surgery decision points.
Is OncoAssure a public or private company?
OncoAssure is a private company. It is classified as venture growth investor backed and is currently operating.
When was OncoAssure founded?
OncoAssure was founded in 2021. It employs 11 to 50 people.
Where is OncoAssure based?
OncoAssure is headquartered in Dublin, Ireland, in the Europe region.
How does OncoAssure make money?
Two revenue lines are on record. Laboratory Diagnostic Testing Services are the primary driver. The others are licensing and Commercialization Partnerships.
Who are OncoAssure's main competitors?
Emerging players on record are Bio-Techne, Strata Oncology and miR Scientific. Direct peers are MDxHealth, Veracyte, Exact Sciences and Myriad Genetics. Broad incumbents are QIAGEN, Cepheid and Hologic.
Does OncoAssure have an API?
No public API is recorded for OncoAssure.
What industry is OncoAssure in?
OncoAssure's product category is Molecular Cancer Diagnostics. Its primary akta.pro industry code is HLAAAMAF, Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk), with a secondary code of HLAAAMAA, Biomarker Discovery & Validation (omics, assay feasibility, clinical validation). Its NAICS code is 621511 and its SIC code is 2835.