Pacific Edge Appoints Chief Commercial Officer

Thursday 27th November 2025

DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today announces the appointment of James Vaughn, R.Ph. 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 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 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.

Pacific Edge Appoints Chief Commercial Officer

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