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U.S. Grants Pacific Edge Patent for Melanoma Detection

DUNEDIN, New Zealand and HERSHEY, Pa., Sept. 4, 2014 /PRNewswire/ -- The United States Patent and Trademark Office has granted Pacific Edge Limited, a cancer diagnostics company, U.S. Patent Number 8,822,149 covering "Prognosis Prediction for Melanoma Cancer." The patent covers the technology being used to develop a melanoma prognostic test that will enable clinicians to distinguish aggressive and life threatening melanomas from those that are not as aggressive.

Pacific Edge Diagnostics USA Logo.

"It is the aggressive tumours that will kill you," Pacific Edge Chief Executive Officer David Darling said.

The test applies a gene signature to a tissue sample taken from the melanoma to detect its aggressiveness, allowing clinicians to prescribe the appropriate level of treatment. Specifically, the test in development identifies aggressiveness in Stage III melanomas.

Pacific Edge partnered with the Ludwig Institute of Cancer Research, the world's largest not-for-profit cancer research organisation, to develop the technology. This successful partnership has enabled Pacific Edge to develop its prototype product for detecting aggressiveness in Stage III melanomas.

The United States is the third jurisdiction after China and New Zealand to grant patent protection for the 'Prognosis Prediction for Melanoma' test, which is in the development stage.

The melanoma test is one of several cancer products that the company has worked up to prototype level prior to focusing resources on the successful launch and further development of its Cxbladder technology for detecting and managing bladder cancer. Cxbladderdetect is now being commercialised in the United States, New Zealand, Australia, and soon in Spain.  The second product in the program, Cxbladdertriage, is scheduled for commercial release in New Zealand later this year.

"Pacific Edge was founded to use the latest developments in molecular biology to provide actionable diagnosis that can contribute to a clinically meaningful difference in cancer detection and the management of that cancer. It is the driving force of our research and product development program," Mr. Darling said.

"Cxbladder is a prime example of our development efforts. It is a quick, cost-effective, non-invasive and highly accurate cancer detection test that enables clinicians to detect urothelial carcinomas, including cancers of the bladder, from a small urine sample."

Pacific Edge's ongoing development program includes clinical and 'User Programs' to validate Cxbladdertriage, a new product positioned to enable physicians and clinicians to segregate out patients who have presented to the clinician with blood in their urine, but who do not have bladder cancer  -- thereby saving considerable clinical work-up cost. Another of the company's products in late-stage development and validation is Cxbladderpredict, a product that will enable clinicians to determine the severity of bladder cancer disease and enable them to non-invasively segregate superficial tumours from invasive tumours.

The company's intellectual property portfolio continues to grow and includes patents for a gastric cancer test as well as melanoma and bladder cancers.

"We are now leveraging the experience gained in launching Cxbladder to the world's largest health care market, the United States, into other products for that market. We are also now looking to other targeted international markets," David Darling commented.

ABOUT Cxbladder
The Company's first product to reach the market is Cxbladder, a proprietary, accurate molecular diagnostic test that enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of urine. Cxbladder was commercialised in New Zealand and Australia in 2012 and the USA in 2013 as a Laboratory Developed Test (LDT).  It provides physicians and clinicians 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 Cxbladder cancer detection test has been validated by a multicentre, international clinical study.  Results published in the Journal of Urology (Sept 2012) 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 as well as greater than 95% of high grade tumours.  For more information, please visit http://www.cxbladder.com

ABOUT BLADDER CANCER
Globally, bladder cancer has the 9th highest incidence and the 4th highest incidence for men. One of the early symptoms of bladder cancer is the presence of blood in the urine, haematuria. People with haematuria often present to their general practitioner before being referred on to a urologist.

There are a number of 'at risk' occupations that have shown a much higher incidence of bladder cancer. Fire fighters and fire control officers have shown in a US study to have a twice the incidence of bladder cancer over non fire fighters. Smoking is a significant contributing factor (over 50% in males and 33% in females, and approximately one of every two new incidences of bladder cancer is linked to smoking). Exposure to certain industrial chemicals or carcinogens increases risks for some occupations e.g. hairdressers, painters, printers, fire fighters and metal workers and chemical engineers. Incidence increases with age so the older you are, the greater the potential for bladder cancer.

Bladder cancer has a very high recurrence rate of approximately 50%-70% with up to 30% of these recurring as later stage tumours. This is a higher recurrence than for skin cancer! However, bladder cancers are highly treatable, especially if detected in the early stages. If diagnosed early there is a much higher probability of survival for early stage tumours relative to later stage tumours. This makes timely and regular surveillance and monitoring of this cancer a key element of the clinical process and of the individual's annual healthcare plan.

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 completed and released its first product for the detection of bladder cancer, Cxbladder, and is actively marketing the product to physicians and clinicians in New Zealand, Australia and the USA 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

For more information contact:

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

Logo - http://photos.prnewswire.com/prnh/20131015/MM98246LOGO

SOURCE Pacific Edge Diagnostics USA LTD

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