Pacific Edge

What Pacific Edge does

Pacific Edge Limited (NZX/ASX: PEB) is a New Zealand-headquartered molecular cancer diagnostics company founded in 2001 that develops and commercializes the Cxbladder suite, a portfolio of non-invasive genomic urine biomarker tests designed to detect and risk-stratify urothelial bladder cancer. The core technology analyzes proprietary mRNA and DNA marker panels derived from the company's genetic databases to rule out bladder cancer and prioritize patients for further clinical work-up. Products include Cxbladder Triage (frontline microhematuria evaluation, included in the 2025 AUA Microhematuria Guideline with Level A Evidence), Cxbladder Detect (adjunct diagnostic), Cxbladder Triage Plus (next-generation mRNA+DNA test priced at US$1,328.32 under CMS Gapfill), Cxbladder Monitor (non-invasive surveillance with optional in-home sampling), and Cxbladder Surveillance Plus. The company owns a granted IP portfolio covering bladder, gastric, colorectal and endometrial cancers and melanoma.

The business model is a specialized laboratory testing services operation, processing urine samples through two wholly owned laboratories: a CLIA/CAP/NYS-certified facility in Hershey, Pennsylvania serving the US market, and an ISO 15189:2012-accredited (IANZ) facility in Dunedin, New Zealand serving APAC. Revenue is generated on a per-test basis (US$760 legacy, US$1,328 Triage Plus) from a mix of Medicare, commercial payer reimbursement, and regional public health contracts, including New Zealand's Te Whatu Ora (covering 70% of the NZ population). The go-to-market is enterprise field sales targeting US urology practices and integrated delivery networks, with direct commercial operations in the US, NZ, Australia, and Singapore, and a distributor network covering Southeast Asia, the Middle East, Latin America, and Israel. Customers include Kaiser Permanente, Southern California Permanente Medical Group, Sentara, Highmark, BCBS plans, the US Veterans Administration, TRICARE, Singapore General Hospital, and Te Whatu Ora. In FY26 (year ended March 2026), operating revenue was NZD 11.5M (down 47.4% year-over-year) following a January 2025 Novitas Medicare non-coverage determination; the company is pursuing reinstatement via draft LCD DL40378.

Name

Pacific Edge

Legal name

Pacific Edge Ltd

Website

https://pacificedgedx.com

Company type

Public

Founded year

2001

Operating status

Operating

Headcount range

101–250 employees

Short description

Pacific Edge Limited (NZX/ASX: PEB) is a New Zealand-headquartered molecular diagnostics company that develops and commercializes the Cxbladder suite of non-invasive genomic urine biomarker tests for bladder cancer rule-out and surveillance, serving urology practices, IDNs, and public health systems across 15+ countries.

Ownership category

akta.pro rank

Product category

Molecular Cancer Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

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

akta.pro primary industry

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

akta.pro secondary industries

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Clinical Research & Trial Central Laboratories (HLAFAMAL), Proteomics & Biomarker Analytical Testing (HLAGADAG)

Keywords

• Urinary cancer diagnostics
• Genomic biomarker tests
• Bladder cancer detection
• Molecular diagnostic assays
• Non-invasive cancer screening

Headquarters

HQ city

Dunedin

HQ country

New Zealand

HQ region

Oceania

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Testing Services: Pacific Edge generates revenue through laboratory testing services for its Cxbladder suite of genomic biomarker tests. Tests are priced at US$1,328 for Triage Plus and US$760 for legacy products. Revenue is derived from Medicare, commercial payer reimbursement, and public health contracts. Operating revenue for FY26 was NZD 11.5 million.
2. Public Health Contracts: Revenue from regional public health contracts in New Zealand. In NZ, Cxbladder is available to over 70% of the population through regional public health contracts such as Te Whatu Ora - Southern and Southern District Health Region.
3. Medicare Reimbursement: Revenue from Medicare coverage of Cxbladder tests. The company is seeking claim-by-claim reimbursement for Triage and Triage Plus under a new draft LCD (DL40378). Coverage for intermediate risk microhematuria patients is expected to be finalized by end of 2026.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels6 records

Core offering

Pacific Edge develops and commercializes the Cxbladder suite of non-invasive genomic urine biomarker tests that analyze mRNA and DNA markers to detect and risk-stratify urothelial bladder cancer. The tests include Cxbladder Triage, Triage Plus, Detect, Monitor, and Surveillance Plus, sold to urologists, integrated delivery networks, hospital systems, and public health authorities. Tests are processed in Pacific Edge's own CLIA/CAP/NYS certified laboratory in the US and IANZ ISO 15189 accredited laboratory in New Zealand, reimbursed through Medicare, commercial payers, and public health contracts.

Product overview

Pacific Edge offers the Cxbladder suite of non-invasive genomic urine biomarker tests for bladder cancer diagnosis and management. The portfolio includes: Cxbladder Triage (frontline diagnostic for microhematuria risk stratification), Cxbladder Detect (adjunct diagnostic for inconclusive cases), Cxbladder Triage Plus (next-generation test combining mRNA and DNA markers), and Cxbladder Monitor (surveillance alternative to cystoscopy). The tests analyze biomarker genes at the molecular level to rule out urothelial cancer and are offered directly in New Zealand, Australia, Singapore, and the United States, with distribution in other markets.

Differentiator

Problem solved

Functional benefit

Brands

• Cxbladder: A suite of non-invasive genomic biomarker tests for bladder cancer diagnostics, including Cxbladder Triage, Cxbladder Detect, Cxbladder Triage Plus, Cxbladder Monitor, and Cxbladder Surveillance Plus.
• Cxbladder Triage
• Cxbladder Detect
• Cxbladder Triage Plus
• Cxbladder Monitor
• Cxbladder Surveillance Plus

Products and services

• Cxbladder Triage Frontline diagnostic test optimized to help de-intensify clinical work-up in microhematuria patients with a low probability test result, reducing need for referral and invasive procedures while prioritizing those requiring further investigation. Included in AUA Microhematuria Guideline with Level A Evidence.
• Cxbladder Detect Test optimized for the risk stratification of patients presenting with microhematuria, helping to de-intensify clinical work-up in those with a low probability test result. Also serves as a reliable adjunct when other tests are inconclusive, resolving atypical cytology and equivocal cystoscopy.
• Cxbladder Triage Plus Next generation test combining analysis of mRNA and DNA markers to further improve clinical utility and efficiency. Single test for hematuria evaluation optimized for risk stratification of patients presenting with microhematuria. Medicare price US$1,328.
• Cxbladder Monitor Non-invasive surveillance alternative for patients being monitored for recurrent non-muscle invasive bladder cancer (NMIBC). Can alternate with cystoscopy to de-intensify surveillance with option of in-home sampling.
• Cxbladder Surveillance Plus Next generation test for the surveillance of bladder cancer recurrence, part of the Cxbladder suite.

Quantifiable outcome

• 130,000+ patients tested with Cxbladder through 5,000+ US urologists
• +3 more outcomes

Named customers11 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature5 records

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Oncocyte: Oncocyte is a molecular diagnostics company developing and commercializing tests for transplant monitoring and oncology. Comparable as a small-cap public molecular diagnostics company pursuing reimbursement and clinical adoption in cancer diagnostics.
• Biodesix: Biodesix is a lung cancer diagnostics company offering blood-based genomic and proteomic tests through its CLIA-certified laboratory. Comparable as a small-cap molecular diagnostics company with a single specialty focus, dependent on Medicare and commercial reimbursement.
• Natera: Natera is a molecular diagnostics company with cell-free DNA tests across oncology, women's health, and organ health. Comparable in operating CLIA-certified labs processing proprietary genomic tests reimbursed by Medicare and commercial payers.

Broad incumbents

• Exact Sciences: Exact Sciences is a major cancer diagnostics company best known for Cologuard. Comparable as a non-invasive genomic screening/diagnostics company that has achieved guideline inclusion and broad reimbursement, representing a scaled analog of Pacific Edge's go-to-market model.
• Abbott: Abbott markets Urovysion, a FISH-based urine test for bladder cancer detection, which directly competes with Cxbladder in urology workflows. Comparable as a large incumbent with an established bladder cancer diagnostic already embedded in clinical practice.
• Hologic: Hologic (via its acquisition of Diagnocure/Gen-Probe) markets the NMP22 urine test for bladder cancer. Directly competes with Cxbladder in the bladder cancer rule-out and surveillance market, leveraging Hologic's large diagnostic sales force.
• Guardant Health: Guardant Health is an oncology-focused molecular diagnostics company specializing in liquid biopsy tests for cancer detection and monitoring. Comparable in operating proprietary genomic tests through centralized labs, though serving different cancer types and with significantly larger scale.
• NeoGenomics: NeoGenomics is a leading oncology clinical laboratory services company offering cancer-focused genetic and molecular testing. Comparable in operating specialized oncology labs serving urologists and oncologists, though at much larger scale and broader test menu.

Direct peers

• Veracyte: Veracyte is a molecular diagnostics company with urologic cancer tests (Decipher Prostate) and broader oncology diagnostics. Comparable business model of running proprietary genomic tests through centralized CLIA-certified labs serving specialist physicians.
• MDxHealth: MDxHealth develops and commercializes molecular diagnostics for urologic cancers, including SelectMDx for prostate cancer. Directly comparable to Pacific Edge as a molecular diagnostics company targeting urologists with non-invasive cancer rule-out tests.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/pacificedgeltd
• YouTubeyoutube.com/user/PacificEdgeLtd
• Facebookfacebook.com/PacificEdgeLtd
• LinkedInlinkedin.com/company/pacific-edge-ltd

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries3 records

Funding overview

Funding rounds7 records

Investors2 records

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 Pacific Edge