About Us
Pacific Edge is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria or surveillance of recurrent disease.
Globally, bladder cancer is the 6th most common cancer among men and the 9th most common overall. It has the highest recurrence rate of any cancer, with approximately 70% of bladder cancer patients experiencing recurrence of the disease after tumor removal, leading to regular surveillance of the patient and making bladder cancer the “highest lifetime cost” per patient of any cancer.
Pacific Edge is guided by the mantra that no one should die from cancer and is on a mission to improve patient outcomes and quality of life. To this end, we have developed Cxbladder, a suite of non-invasive genomic urine tests for the risk stratification, rule out, and surveillance of urothelial bladder cancer, the most common form of the disease (> 90% of cases).
Cxbladder
With a non-invasive collection system and the option of in-home sampling, the Cxbladder suite helps to optimize clinical practice workflow, safely sparing low risk patients the discomfort, anxiety and risks of an invasive procedure, while prioritizing higher risk patients for immediate care.
A Global Footprint
Commercially we offer Cxbladder directly in New Zealand, Australia, Singapore, and the United States, our largest and most important market where over 5,000 urologists have now used a Cxbladder test in more than 100,000 patients. In other countries across Southeast Asia, the Middle East and Latin America, we work through a network of distributors. In New Zealand, Cxbladder is now available to over 70% of the population through regional public health contracts.
Clinical Evidence Generation
The Cxbladder evidence portfolio, developed over the past two decades, includes more than 25 peer reviewed publications in leading medical journals. The Cxbladder suite is now the focal point of numerous ongoing and planned clinical studies to drive the increased adoption of the tests globally, supported by coverage decisions from public and private healthcare insurers and urological guideline inclusion.
Research and Development
To drive long-term growth, we invest in technology and product innovation to maintain our leadership position in bladder cancer diagnostics
Our intellectual property covers the areas of bladder, gastric, colorectal and endometrial cancers and melanoma. This wider portfolio is expected to provide us with further options in the future.
Our Laboratories
Pacific Edge has certified laboratories in New Zealand and in the United States.
Both laboratories hold a Certificate of Compliance from the Center for Medicare & Medicaid Services (CMS) for Clinical Laboratory Improvement Amendments (CLIA), which sets the standards for clinical laboratory testing in the United States. In New Zealand, our laboratory is accredited for compliance with the International Standards Organisation for clinical diagnostics laboratories (ISO15189),and with the International Accreditation New Zealand (IANZ). In the United States, our laboratory is accredited with the College of American Pathologists (CAP) and New York State (NYS).
This compliance enables Pacific Edge's laboratories to provide commercial services to clinicians and process urine samples from patients in the United States, New Zealand and other markets for Cxbladder.
Industry Organizations
We work with industry organizations around the world to promote the benefits of non-invasive genomic biomarker testing and to support the continued commercialization and clinical adoption of our diagnostic suite.
