Vesica Health

What Vesica Health does

Vesica Health is a U.S. precision diagnostics company that developed and commercialized AssureMDx, a non-invasive, urine-based molecular diagnostic test designed to aid in the early detection of bladder cancer in patients presenting with hematuria. The test is a laboratory-developed multi-omic assay that interrogates DNA methylation status of the OTX1, ONECUT2, and TWIST1 genes in combination with somatic mutation status of the FGFR3, TERT, and HRAS genes, combined with clinical risk factors to stratify a patient's risk of harboring bladder cancer. Clinical validation in prospective multicenter studies demonstrated 96% sensitivity, 99.7% negative predictive value, and 0.96 AUC across 838 hematuria patients, with performance supported by more than 26 peer-reviewed publications covering over 8,500 patients. The assay is processed in the company's CAP-accredited, CLIA-certified laboratory in Irvine, California, with sample collection kits shipped to physician offices and results returned to the ordering provider.

The company operates a B2B sales motion targeting urologists, primary care physicians, and gynecologists, who order AssureMDx via physician account setup and test requisition forms. Revenue is generated on a per-test basis through laboratory diagnostic testing services, with billing routed to healthcare providers, insurance payers, and Medicare. The company secured a Proprietary Laboratory Analysis billing code (0613U) from the American Medical Association, effective January 2026, and received FDA Breakthrough Device Designation in February 2026 and formal AUA Guideline inclusion in September 2025 — milestones that establish the regulatory and reimbursement pathway required for commercial adoption. Initial revenues were expected to begin in 2027 following Medicare reimbursement decisions, with positive EBITDA contribution anticipated by 2030. Vesica was acquired by Norwegian diagnostics company Photocure ASA on June 4, 2026, for approximately USD 30.5 million in cash and equity (USD 28.5 million net of the company's USD 2 million cash position), with USD 13.75 million paid at close and USD 13.75 million contingent on Medicare reimbursement milestones. Post-acquisition, Vesica operates as a wholly-owned subsidiary within Photocure's bladder cancer diagnostics portfolio.

Name

Vesica Health

Legal name

Vesica Health, Inc.

Website

https://vesicahealth.com

Company type

Private

Founded year

2023

Operating status

Acquired

Headcount range

1–10 employees

Short description

Vesica Health is a U.S. precision diagnostics company offering AssureMDx, a non-invasive urine-based multi-omic molecular test combining DNA methylation and somatic mutation analysis to detect bladder cancer in hematuria patients. Acquired by Photocure ASA in June 2026.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD)

Keywords

• Molecular diagnostics
• Bladder cancer detection
• Urine biomarker testing
• Liquid biopsy assays
• Genomic hematuria evaluation

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Laboratory Diagnostic Testing Services: AssureMDx is offered as a laboratory-developed test (LDT) performed in Vesica's CAP-accredited, CLIA-certified laboratory. Revenue is generated through per-test billing to healthcare providers, insurance payers, and Medicare. The company secured an AMA PLA billing code (0613U) effective January 2026, establishing a recognized reimbursement pathway. Initial revenues expected in 2027 following Medicare reimbursement decisions, with positive EBITDA contribution anticipated by 2030.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Vesica Health operates a CAP-accredited, CLIA-certified clinical laboratory that offers AssureMDx, a proprietary, non-invasive urine-based multi-omic molecular test for early detection of bladder cancer in hematuria patients. The test analyzes DNA methylation status of OTX1, ONECUT2, and TWIST1 genes combined with somatic mutation status of FGFR3, TERT, and HRAS genes, alongside clinical risk factors, to stratify patients by bladder cancer risk and inform urology referral decisions. The company sells the test directly to physicians (urologists, primary care physicians, gynecologists) and bills payers using AMA PLA code 0613U.

Product overview

Vesica Health offers a single flagship product, AssureMDx, a proprietary multi-omic urine-based genomic test for early bladder cancer detection. The test analyzes six DNA biomarkers (three methylation markers and three somatic mutations) combined with clinical risk factors to stratify hematuria patients by bladder cancer risk. AssureMDx is offered as a laboratory-developed test (LDT) performed in the company's CAP-accredited, CLIA-certified laboratory and is designed to be ordered by licensed physicians to support risk-based triage decisions in the bladder cancer diagnostic pathway.

Differentiator

Problem solved

Functional benefit

Brands

• AssureMDx: A proprietary, non-invasive urine-based DNA test designed to improve early detection of bladder cancer by analyzing DNA methylation (TWIST1, OTX1, ONECUT2) and somatic mutations (FGFR3, HRAS, TERT) biomarkers. The test helps identify hematuria patients at increased risk for bladder cancer for expedited urological evaluation.

Products and services

• AssureMDx Proprietary, non-invasive urine-based multi-omic DNA test that evaluates DNA methylation status of OTX1, ONECUT2, and TWIST1 genes combined with somatic mutation status of FGFR3, TERT, and HRAS genes for early detection of bladder cancer in hematuria patients. Performed as a laboratory-developed test in Vesica's CAP-accredited, CLIA-certified laboratory and ordered by licensed physicians to provide binary results for urology referral decisions.

Quantifiable outcome

• 96% sensitivity for bladder cancer detection across all hematuria patients
• +5 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Photocure ASAcoreStrategic or Co-development Partner · 4 June 2026Photocure ASA completed acquisition of Vesica Health on June 4, 2026, in a transaction valued at approximately USD 30.5 million (USD 28.5M net after Vesica's cash). Deal includes USD 13.75M at close (USD 11M cash + USD 2.75M equity) and up to USD 13.75M tied to Medicare reimbursement milestones. The acquisition extends Photocure's bladder cancer diagnostics portfolio with AssureMDx, leveraging Photocure's established commercial infrastructure, urology footprint, and payer relationships.
• Bon Secours Mercy HealthminorOthers · 7 January 2026Dr. William T. Lowrance, CMO of Vesica Health, continues medical practice at Bon Secours Mercy Health while serving as Chief Medical Officer. This represents a clinical practice partnership rather than commercial partnership.
• Board of Directors (Dr. Jan Groen, Mark McDonough, Joe Sollee)coreOthers · 19 October 2023Three industry veterans appointed to Board of Directors with expertise spanning genomics, molecular pathology, diagnostics operations, finance, reimbursement, and corporate governance. Dr. Jan Groen (Chair) formerly CEO at MDxHealth; Mark McDonough formerly CEO at ChromaCode and PierianDx; Joe Sollee EVP at MDxHealth.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MDxHealth: MDxHealth is the most direct competitor, offering SelectMDx and ConfirmMDx — urine-based molecular diagnostic tests for prostate and bladder cancer. Both companies target the uro-oncology diagnostic market with biomarker-based approaches; Vesica's Board Chair Dr. Jan Groen is the former CEO of MDxHealth.
• Pacific Edge Diagnostics: Pacific Edge Diagnostics offers Cxbladder, a urine-based genomic test for bladder cancer detection and monitoring. Direct competitor in the same clinical workflow with comparable target customer base of urologists and primary care physicians managing hematuria patients.
• Nonagen Bioscience: Nonagen Bioscience has developed Oncuria, a multiplex urine protein biomarker test for bladder cancer detection. Competes with AssureMDx in the same clinical indication with a different biomarker modality but comparable physician ordering and lab-testing business model.

Broad incumbents

• Photocure ASA: Photocure ASA acquired Vesica Health in June 2026 and now owns AssureMDx. Photocure's existing Hexvix/Cysview blue light cystoscopy product is a complementary bladder cancer diagnostic — together the portfolio covers the full bladder cancer care continuum from detection through treatment.
• Hologic: Hologic is a large diversified diagnostics company offering cytology solutions (ThinPrep) and the Aptima HPV assay. Its urological cytology workflow is a competitor to AssureMDx in the hematuria evaluation pathway, and Hologic's scale represents a competitive threat to smaller specialty diagnostics.
• Exact Sciences: Exact Sciences pioneered Cologuard for colorectal cancer screening — a direct precedent for non-invasive genomic cancer detection tests. Their scale, commercial infrastructure, and demonstrated playbook for guideline inclusion and reimbursement could position them to enter the bladder cancer diagnostic space competitively.
• Cepheid (Danaher): Cepheid, a Danaher subsidiary, operates the GeneXpert molecular diagnostics platform widely deployed in clinical laboratories. Their established PCR-based testing infrastructure and broad infectious disease / oncology menu make them a potential competitive threat or partner for urine-based cancer diagnostics.
• Guardant Health: Guardant Health is a leading liquid biopsy company offering Guardant360 for tumor profiling and Reveal for MRD. While focused on blood-based testing, their molecular diagnostics infrastructure and commercial reach represent a competitive threat if they expand into urine-based bladder cancer detection.

Emerging players

• Natera: Natera offers cell-free DNA and molecular diagnostic tests, including Signatera for cancer recurrence monitoring. Their expertise in circulating tumor DNA and laboratory-developed tests positions them as a potential entrant into the urine-based bladder cancer diagnostic market.

Others

• Bio-Techne: Bio-Techne provides research reagents, diagnostic components, and analytical tools used by molecular diagnostics developers. As an enabler/supplier to the diagnostics industry, they represent an ecosystem participant rather than a direct competitor, but their ExoDx Prostate Test places them adjacent in the urology diagnostic space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/vesica-health-inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Vesica Health