Pacific Edge Launches Cxbladder Monitor™ in the United States

DUNEDIN, New Zealand and HERSHEY, Pa., Dec. 12, 2016 /PRNewswire/ -- Pacific Edge Limited (NZX:PEB) ("Pacific Edge"), a cancer diagnostics company developing and commercializing a suite of non-invasive tests for the detection and management of bladder cancer, announced today the commercial launch of the third product in the Company's Cxbladder™ family of products, Cxbladder Monitor™, 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 hasn't 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.

David Darling, Chief Executive Officer of Pacific Edge, stated, "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. 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."

Jackie Walker, Chief Executive Officer of the Company's US commercial operations, added, "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 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 5^th 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 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.

About Bladder Cancer
Approximately seven million people in the USA exhibit hematuria (blood in the urine) each year, of which approximately more than one million patients are evaluated to determine the cause of their hematuria, costing the USA healthcare system in excess of $1.5 billion per annum.  Bladder cancer is the ninth most prevalent form of cancer but the 4^th most prevalent in men. It has a very high recurrence rate and often progresses quickly to a later stage disease.  However, bladder cancers are highly treatable, especially if detected in the early stages. This combined with regular surveillance of patients who are on an extensive program of monitoring for the recurrence of bladder cancer to provide patients with the potential for a better outcome. The current average cost per bladder cancer patient in the USA is estimated to approach $240,000, the highest total medical cost per patient of any all cancers, from diagnosis to death.  Early detection and improved monitoring have the potential to lower total healthcare costs and improve patient outcomes.

About Cxbladder™
Cxbladder provides a suite of non-invasive, accurate and easy to use tests for the detection and management of bladder cancer.  Pacific Edge's 'one stop shop' of Cxbladder products is designed to meet the specific clinical needs of physicians and urologists managing the different patient groups, from early detection through to monitoring and management.  More accurate than currently available urine-based cancer detection tests, Cxbladder gives patients and physicians additional resolution and further confidence in their clinical evaluations and diagnoses.  Cxbladder combines the expression of genes and clinical and patient variables factors that create unique molecular signatures for urothelial carcinoma, the most common form of bladder cancer.

About Pacific Edge Limited
Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer diagnostic company specializing in the discovery and commercialization of diagnostic and prognostic tests for better detection and management of cancer. The Company is developing and commercializing its range of Cxbladder tests, which have been tested and validated in international multicenter clinical studies for bladder cancer globally through its wholly-owned central laboratories in New Zealand and the USA.  Pacific Edge currently has three proprietary, novel, accurate, molecular diagnostic products in-market providing actionable results, and better detection and management of urothelial cancer. Cxbladder Detect and Triage are available through the company's dedicated CLIA-certified laboratories for customers in New Zealand, Australia and the USA. Cxbladder Monitor launched in New Zealand in December 2015 and has launched in the USA in 2016.

SOURCE Pacific Edge Limited