Pacific Edge CEO to present data from its recently published STRATA¹ study at the Urological Association of Asia (UAA) Congress and attended signing event for lab partnership agreement in Malaysia.

Pacific Edge today announces its medical presence at the UAA Congress to be held in Bali this week (September 5-8), which has attracted a record attendance of more than 2800 urologists.

Pacific Edge CEO, Dr Peter Meintjes will present the clinical utility evidence from the STRATA study to an APAC audience for the first time. STRATA is the first randomly controlled trial of a urine-based biomarker for hematuria evaluation ever completed. It demonstrated that presenting clinicians with a Cxbladder Triage result led to a 59% reduction in cystoscopies, the primary endpoint of the study.

Supporting Pacific Edge’s presence at the meeting are independent presentations by Dr Arjun Guduguntla of Northern Health in Melbourne who will be presenting on Proposed novel surveillance schedule using Cxbladder Monitor for patients on annual bladder surveillance and Dr Prasanth Anton Sagayanathan from Sunshine Coast University Hospital who will be presenting on Clinical utility of Cxbladder in detecting bladder cancer in a far north Queensland (Australia) population.

Pacific Edge Chief Executive Dr Peter Meintjes said: “It is outstanding to see our long-standing customer and clinical study partners in Australia sharing their experience of Cxbladder with the broader community in the Asia Pacific region. Real world evidence is the ideal complement to the clinical utility evidence generated from our core evidence generation program and the UAA Congress provides a great platform to communicate this evidence to APAC urologists.”

Prior to the activities at the UAA Congress Dr Meintjes visited Malaysia for a ceremonial signing of an already-signed distribution agreement with Premier Integrated Labs supported by New Zealand Trade and Enterprise and attended by the Prime Minister, the Right Honourable Christopher Luxon at the Shangri-La hotel in Kuala Lumpur. Premier Integration Labs is the sole supplier of laboratory services to IHH Healthcare – that includes the three largest individual hospitals in Malaysia².

Pacific Edge Chief Executive Dr Peter Meintjes said: “This partnership represents a further advance in our strategy to expand the availability of Cxbladder and improve patient lives across key international markets.

“Premier Integrated Labs’ extensive network of labs, combined with its expertise in advanced diagnostics is an ideal partner to help integrate Cxbladder tests into local standards of care, enhancing bladder cancer detection and management across Malaysia.”

Premier Integrated Labs Chief Executive Officer, Mohd Hareeff Bin Muhammed said: "We are delighted to bring Cxbladder to our hospital group. It offers patients non-invasive testing specifically designed to help rule out bladder cancer in those experiencing hematuria and to monitor for recurrent disease.

The agreement adds to Pacific Edge’s network of international distribution partnerships, which now covers Israel, Latin America and several countries in Asia. In each case Pacific Edge provides comprehensive support to its distribution partners, including education and training, logistical support, and assistance with country-specific registration and market access requirements.

“While we anticipate that volumes from these new markets may be modest in the short and medium term, the long-term potential is more substantial. As the clinical value of our tests becomes recognized by urological communities, the cumulative volume across these territories has the potential to add meaningfully to the Pacific Edge,” Dr Meintjes said.

“By partnering with well-established organizations that have strong relationships with clinicians and healthcare decision-makers, we can ensure that Cxbladder is effectively integrated into local healthcare practices,” added Dr. Meintjes. “We are confident that Premier Integrated Labs will play a crucial role in driving the adoption of Cxbladder in Malaysia, ultimately improving patient outcomes.”

Images of the signing can be viewed and downloaded from the following links:

Image 1: Agreement Signing

Image 2: Agreement Completed

Back left: Suzy Fewtrell, Trade Commissioner to Malaysia and Thailand
Back right: Rt Hon Christopher Luxon, New Zealand Prime Minister
Front left: En. Mohd Hareeff Bin Muhammed, CEO, Premier Integrated Labs
Front right: Peter Meintjes, CEO, Pacific Edge

¹ Lotan et al. (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
² This agreement complements the non-exclusive distribution agreement Pacific Edge has signed with Wellspring Medical for broader distribution across Malaysia.