Cxbladder User Program research agreement signed with Kaiser Permanente Southern California

DUNEDIN, New Zealand and HERSHEY, Pa., Sept. 3, 2014 /PRNewswire/ -- Pacific Edge Ltd, a cancer diagnostics company, has signed an agreement with Southern California Permanente Medical Group (SCPMG) to research its User Program to evaluate its bladder cancer technology Cxbladder within the clinical settings of Kaiser Permanente's health care network.

The Kaiser Permanente User Program research project is planned to recruit approximately 2000 patients presenting with microscopic and macroscopic hematuria (blood in the urine), from the 3.7 million members of Kaiser Permanente Southern California.

The User Program research is scheduled to begin later this year with results completed in early 2015.

Pacific Edge Chief Executive Officer David Darling said, "User Programs are a key part of the adoption process where customers are able to obtain data and specific experience of the benefits of using the Cxbladder technology in their own clinical settings."

Operating in eight states, Kaiser Permanente is one of America's leading health care providers with a not-for-profit health plan. With their provision of services to 9.5 million people, Kaiser Permanente cares for a population twice the size of all of New Zealand's District Health Boards.

Cxbladder is targeted to provide clinicians with a means to identify patients with a high degree of surety who do not have bladder cancer. It is anticipated that significant advantages will accrue to both the patient and the health care provider from the successful integration of Cxbladder into the clinical setting. Typically less than 5 per cent of those patients who present to their clinician with microscopic hematuria (non-visible blood in urine of clinical significance) will be diagnosed with bladder cancer and approximately 12 per cent of those patients who present with visible blood in their urine.  At present nearly all patients with hematuria are currently required to have an expensive clinical work-up to identify those requiring further investigation.

User Program samples collected in Cxbladder's proprietary urine sampling system will be sent to PED_USA, Pacific Edge's purpose built laboratory in Hershey, Pennsylvania for the laboratory analysis. Cxbladder results will be collated with clinical information and analysed by an independent team at SCPMG.

Pacific Edge Diagnostic USA CEO Jackie Walker said, "Kaiser Permanente is well regarded in the medical community for providing the highest standards of health care for its members through development and early adoption of industry leading technology."

Results from the peer reviewed multi-centre Cxbladder clinical trial of 485 patients published in the prestigious Journal of Urology in the United States in September 2012 showed that Cxbladder outperformed all other benchmark technologies used in the trial and identified nearly all tumours of interest to clinicians.

Cxbladder is currently being evaluated in New Zealand for a similar clinical value proposition by Mid-Central District Health Board in Palmerston North. The commercial evaluation by Mid-Central DHB is to establish the levels of patient benefits and savings that can be achieved from the use of Cxbladder in a similar clinical setting to Kaiser Permanente by ruling out patients referred with micro-haematuria who do not have bladder cancer.

ABOUT PACIFIC EDGE
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic company specialising in the discovery and commercialisation of diagnostic and prognostic technology for the early detection and monitoring of cancer.

Products in development and in clinical trials are accurate and simple to use genomic and proteomic tools for the earlier detection, improved characterisation and better management of gastric, bladder, colorectal cancers and melanoma. The company has recently completed and released its first product for the detection of bladder cancer, Cxbladder, and is actively marketing the product to urologists in New Zealand, Australia and the US and soon in Spain. For more information, please visit http://www.pacificedge.co.nz

ABOUT PACIFIC EDGE DIAGNOSTICS
Pacific Edge takes its exciting cancer detection tests to market through its wholly owned subsidiaries, Pacific Edge Diagnostics NZ Ltd and Pacific Edge Diagnostics USA Ltd, and selected commercial partners in Australia and Spain, Healthscope and Oryzon respectively. For more information, please visit http://www.pacificedgedx.com

ABOUT Cxbladder
Cxbladder is a proprietary, accurate molecular diagnostic test that enables the non-invasive detection of bladder cancer from a small volume of urine. It provides general practitioners and urologists with a quick, cost effective and accurate measure of the presence of the cancer, and provides urologists with the opportunity to reduce their reliance on the need for invasive tests such as cystoscopy. The recently published, Journal of Urology in September 2012, multi-centre international clinical study recruited 485 patients from Australia and New Zealand.

Results show that Cxbladder out-performed all of the benchmark technologies in the clinical trial and detected nearly all of the tumours of concern to a urologist; At a performance of 82% sensitivity and 85% specificity the test sees 100% of T1, 100% of T2, 100% of T3, 100% of Tis and 100% of upper urinary tract cancers and 97% of high grade tumours. For more information, please visit http://www.cxbladder.com

For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800

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SOURCE Pacific Edge Diagnostics USA LTD