Pacific Edge announces commercial launch of Cxbladder Monitor in the U.S.

Breakthrough in clinical utility for urologists managing bladder cancer patients

Pacific Edge Limited (NZX:PEB), a cancer diagnostics company developing and commercializing a suite of non-invasive tests for the detection and management of bladder cancer, announces today the commercial launch of the third product in the Company's Cxbladder(TM) family of products, Cxbladder Monitor(TM), in the United States.

Cxbladder Monitor is a urine-based gene expression test for the investigation of bladder cancer in patients who are being actively monitored for recurrent disease. It is designed to be used on patients as part of their ongoing surveillance regime to quickly and accurately identify those who have a low probability of having recurrent cancers. Cxbladder Monitor provides reassurance to clinicians and their patients that their cancer has not returned or supports further urological investigation.  

Cxbladder Monitor has recently been accepted for publication by the Journal of Urology profiling the excellent performance of this test with real world data on over 1100 patient samples. It has been commercially available in New Zealand since December 2015 and was recently adopted by a large public healthcare provider in New Zealand for patients undergoing routine surveillance for bladder cancer recurrence.

Pacific Edge is the only company in the world to offer a suite of molecular diagnostic tests in bladder cancer, with three tests currently in the market and an additional test expected to launch in the US in 2017.

“We are very excited about Cxbladder Monitor's launch in the US, joining our other two products - Cxbladder Triage which helps to rule out cancer in patients who have a low probability of having bladder cancer; and Cxbladder Detect which is used specifically to detect bladder cancer,” said David Darling, Chief Executive Officer of Pacific Edge. “Our latest product, Cxbladder Monitor, will provide urologists who are evaluating patients for the recurrence of the disease with greater certainty of their clinical evaluations, and will provide patients with a non-invasive way to monitor their disease."

"This test provides a step change in clinical utility by providing physicians and patients an accurate, non-invasive test to identify patients who have a very low probability of bladder cancer recurrence throughout their often, extensive regime of surveillance,” said Jackie Walker, US commercial operations CEO, Pacific Edge. “These patients may not therefore need a cystoscopy or other invasive work-up or can increase the intervals between invasive work-ups, reducing costs and improving quality of life. We are seeing steady growth in the adoption of Cxbladder Detect and Triage in the US. Now with the addition of Cxbladder Monitor, we expect to see a significant increase in sales. Over 7 million people in the United States present annually with hematuria (blood in the urine), a symptom of bladder cancer. Bladder cancer is the 5th most prevalent cancer in the USA with a recurrence rate of up to 70 percent. Many people can be monitored for most of their life with expensive and invasive tests. As a result, it has the highest total medical costs of any cancer over the lifetime of the patient. The current practice of evaluation for recurrence of bladder cancer involves invasive and expensive tests and has a significant impact on patients and their compliance. Cxbladder Monitor is a simple, accurate and non-invasive test and we expect it to be in strong demand by physicians and patients alike."

This year, Pacific Edge has entered into contract with the Veterans Health Administration (VA) and the TRICARE Health Plan Network. Between them, these two programs provide coverage to approximately 13 million US veterans, active military and their families. The VA and TRICARE are two of Pacific Edge's targeted large-scale customers.