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Pacific Edge Appoints Chief Commercial Officer

Director Appointment26 November 2025PEBHealthcare

27 NOVEMBER 2025



PACIFIC EDGE APPOINTS CHIEF COMMERCIAL OFFICER

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today

announces the appointment of James Vaughn, R.Ph.

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into the new role of Chief Commercial

Officer (CCO) to drive the adoption of Cxbladder. This follows the departure of David Levison

as President of Pacific Edge Diagnostics USA (PEDUSA) following 10 years of service to

pursue other opportunities.

Mr Vaughn was most recently the Chief Commercial Officer of diagnostics firm ClearNote

Health that develops liquid biopsy tests in various oncology disciplines. Prior to his role at

ClearNote, Mr Vaughn held multiple roles over 17 years at Genomic Health, with the last seven

of those years as Chief Commercial Officer. Genomic Health pioneered the Lab Developed

Testing for advanced oncology testing in the US. The success at driving revenue from

Oncotype Dx Breast under Mr Vaughn’s commercial leadership was an important driver of

Genomic Health’s price at acquisition by Exact Sciences for $2.8 billion in July 2019.

Mr Vaughn is an experienced commercial leader, bringing to Pacific Edge more than 30 years’

experience across the pharmaceutical, medical device, and clinical diagnostics sectors and a

track record of successful new product commercialization that is ideally suited to the stage of

growth of Pacific Edge. Although Oncotype Dx Prostate was pre-commercial during his tenure

at Genomic Health, he also developed a network among the key opinion leaders in urology.

Pacific Edge Chief Executive Dr Peter Meintjes said he was delighted Mr Vaughn had accepted

the CCO role — a position created to lead the company’s commercial execution globally,

following the company-defining inclusion of Cxbladder Triage in the American Urological

Association (AUA) guideline for the evaluation of microhematuria.

Dr Meintjes said: “With the AUA guideline now recommending the use of Cxbladder Triage in

intermediate-risk patients, Pacific Edge is seeking to maximize the growth of Triage in the

testing of these patients across all payer categories – Medicare, Medicare Advantage and

Commercial Payers. Our future commercial success will be driven by a strong focus and

disciplined execution across the commercial organization, and we are delighted to bring an

experienced commercial leader into this role focused solely on throughput and growth through

sales, marketing and market access.

“After a thorough search, we identified Jim as uniquely experienced to capitalize on the

guideline language to drive the adoption of Cxbladder by physicians for their patients

presenting with microhematuria. His experience at Genomic Health in promoting Oncotype Dx

Breast, the pioneering company and test for our broader industry that all other molecular

diagnostic companies aim to emulate, was highly determinative of his success in securing this

role.

“Similarly, the urology network he developed during the pre-commercial stages of Oncotype

Dx Prostate create a great opportunity for the commercial team going forward. Driving


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Registered Pharmacist



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behavioral change is at the core of what we do, and he has excelled at achieving this in his

prior role, regularly beating market guidance and expectations.”

Mr Vaughn, who takes up the role on 1 December 2025, said: "Promoting Cxbladder tests is

an exciting opportunity. Pacific Edge has already achieved guideline inclusion – a major

strategic milestone and de-risking event for the company – but the company’s ongoing

commitment to analytical validation, clinical validation and clinical utility with studies like

CREDIBLE for Triage Plus, and OCTOPUS for Surveillance Plus highlighted for me the

enormous growth potential in diagnostic testing for non-muscle invasive bladder cancer.

“Similarly, the soon-to-be published real-world evidence study from Kaiser Permanente

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presented at the 2025 AUA meeting, shows the performance is here today for the existing

products. Having navigated similar challenges where a non-invasive diagnostic test, like

Cxbladder, displaces an existing procedure, I am confident that we have the evidence today to

grow month-over-month, quarter- over-quarter selling to clinicians and to further improve our

reimbursement rates with commercial payers.”

Prior to joining Genomic Health and ClearNote Health, Mr Vaughn was the VP Marketing and

Scientific Affairs at the Cerus Corporation, was a Global Marketing Director at GD Searle & Co

(a Pfizer Subsidiary) that included a focus on the European market and Managed Care roles

with IMMUNEX developing reimbursement strategies for medical policy, contracting and

training. He has an MBA from the Kellogg School of Business at Northwestern University and

a bachelor’s in pharmacy from Creighton University.

“Looking further ahead, Pacific Edge has developed core expertise that positions it well to think

about opportunities beyond bladder cancer and beyond our existing markets. I’m excited by

the chance to leverage recent wins to drive adoption across the US and other international

markets. I am looking forward to getting started at the Society for Urologic Oncology (SUO)

Meeting in December, where we have an active clinical and commercial program,” Mr Vaughn

said.

Investors: Media:

Dr Peter Meintjes Richard Inder

Chief Executive The Project

Pacific Edge P: +64 21 645 643

P: 022 032 1263

OVERVIEW

Pacific Edge: www.pacificedgedx.com

Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way

in the development and commercialization of bladder cancer diagnostic and prognostic tests


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Loo R.K., et al (2025) Clinical Utility of a Urine Biomarker (Cxbladder Triage) Compared to a Standard

of Care for Microscopic Hematuria Evaluations in a Large Independent Delivery Network. Abstract

submitted to the AUA 2025 meeting.



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for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in

Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its

wholly owned, and CLIA certified, laboratories in New Zealand and the USA.

Cxbladder: www.cxbladder.com

Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of

urothelial cancer in patients presenting with microhematuria and those being monitored for

recurrent disease. The tests help improve the overall patient experience, while prioritizing time

and clinical resources to optimize practice workflow and improve efficiency.

Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than

25 peer reviewed publications, and Cxbladder Triage is now included in the American

Urological Association’s Microhematuria Guideline. To drive increased adoption and improved

patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies

designed to generate further clinical utility evidence.

Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and

South America. In the US, the test has been used by over 5,000 urologists who have ordered

more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the

population via public healthcare and all residents have the option of buying the test online.

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