Ann: GENERAL: PEB: Cxbladder User Program research agreement signed

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• Summary: GENERAL: PEB: Cxbladder User Program research agreement signed
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					PEB
27/08/2014 10:03
GENERAL

REL: 1003 HRS Pacific Edge Limited

GENERAL: PEB: Cxbladder User Program research agreement signed

27 August 2014

Cxbladder User Program research agreement signed with Kaiser Permanente
Southern California

Pacific Edge Ltd 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 David Darling says 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 PEDUSA, the Company'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 says "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.

For more information contact:

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

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.

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.

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.

www.cxbladder.com
End CA:00254465 For:PEB    Type:GENERAL    Time:2014-08-27 10:03:29