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Official Launch of Cxbladder Monitor in the USA

Company Announcement
13 December 2016


Cancer diagnostics company, Pacific Edge Limited (NZX:PEB) has commenced the official USA launch of its third bladder cancer diagnostic test, Cxbladder Monitor.

Cxbladder Monitor is Pacific Edge’s third test in its Cxbladder suite of simple, accurate and non-invasive bladder cancer diagnostic tests and has been 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 hasn’t returned or supports further urological investigation.

Publication of a paper confirming the superior performance of Cxbladder Monitor in ruling out the recurrence of bladder cancer was recently accepted for publication by the Journal of Urology, providing launch momentum for the new product in the USA. The test has been commercially available in New Zealand since December 2015 and was recently adopted by Auckland’s Waitemata District Health Board in New Zealand for patients undergoing routine surveillance for bladder cancer recurrence.

David Darling, Chief Executive Officer of Pacific Edge, stated: “We are very excited about Cxbladder Monitor’s launch in the USA, 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.

“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. 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 USA. 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 heamaturia (blood in the urine), a symptom of bladder cancer, annually. Bladder cancer is the 5th most prevalent cancer in the USA with a recurrence rate of up to 70%. 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 TRICARE Health Plan Network. Between them, these two programmes provide cover to approximately 13 million USA veterans, active military and their families. The VA and TRICARE are two of Pacific Edge’s targeted large-scale customers.

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


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