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Pacific Edge - CEO presentation at AGM

Summary of Chief Executive’s presentation to the Annual Shareholders Meeting held in Dunedin on 23 August 2012

27 August 2012
Key points:
• The roll out of Cxbladder® in the USA and commissioning of purpose built laboratory testing centre in Hershey, Pennsylvania proceeding on schedule and to budget.
• Interest in Cxbladder® from urologists, general practitioners and medical specialists attending GPCME (GP Continuing Medical Education) conferences in North Island in June and the South Island in August
• American Journal of Urology has published the peer reviewed science paper of the results of the international multicentre Cxbladder® clinical study.
• Cxbladder® launched in Australia by licensed partner Healthscope
• Cxbladder® is on-track to launch in Spain and Portugal later this year with licensed partner, Oryzon
The last 12 months had been momentous for Pacific Edge Limited and the roll out of its first diagnostic cancer test, Cxbladder®, Chief Executive David Darling told the annual shareholders meeting in Dunedin on 23 August 2012.

“Over the next 12-18 months Pacific Edge will continue with the transformation from research operation to a world-leading cancer molecular diagnostics company providing high performance cancer detection tools to aid clinicians in the detection and management of cancers.”

With the recent appointment of Jackie Walker as the CEO of the wholly owned subsidiary Pacific Edge Diagnostics USA, the company had gained an executive with global experience with large corporates and start-ups in the life sciences and medical device industry. Leading the US business, Jackie is now putting place a team with the sales and marketing experience to roll-out Cxbladder® to urologists, health services providers, health service funders and insurers in the US.

“Using funds from the successful capital raise undertaken last year, the business in the United States is on schedule and running to budget. The purpose built testing laboratory being commissioned at Hershey, Pennsylvania is at a key location on the eastern seaboard, with 58 million people within a 90 minute radius. The laboratory is also close to a hub of one of the largest courier operators in the USA.”

During the last year, Pacific Edge licensed Healthscope Pathology in Australia to market Cxbladder® there. Healthscope’s laboratory completed the adoption and validation of Pacific Edge’s Cxbladder® technology in February 2012. The laboratory is now underway with the commercial analysis of Cxbladder® tests for Australian urologists

In Spain and Portugal, which have the fourth highest incidence of bladder cancer in the world, Oryzon, a leading molecular diagnostic testing organisation, is marketing Cxbladder®. Oryzon’s laboratory is expected to begin commercial analysis later this year.

“In New Zealand, the interest from the medical profession in Cxbladder®, a simple-to-use and non-invasive test for patients presenting with hematuria (a prime indicator of bladder cancer), is very strong,” Pacific Edge introduced Cxbladder® to GP’s urologists and other specialists at the recent GP Continuing Medical Education conferences in Rotorua earlier this year and in Dunedin in the last month.

“Urologists, General Practitioners and other medical specialists quickly understood that their patients would readily provide a simple urine sample rather than undergo the invasive, uncomfortable procedures and that this test provides valuable information for them to help with their clinical needs in detecting and managing haematuria and bladder cancer.”
Appreciation of Cxbladder®’s potential is growing steadily since publication in the American Journal of Urology in July, online (and in the September print edition) of the results of the Cxbladder® clinical study.
“Cxbladder® is now being discussed on blog websites used by patients with bladder cancer where a common theme is their concern at having to undergo the regular invasive check-ups that they currently endure. The patients see Cxbladder® as an option for themselves and are lobbying urologists to incorporate it in their programme. “
Cxbladder® continues on its schedule to launch in March 2013 in the United States, the largest market for medical applications.

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 soon to be Spain and Portugal and the US.

ABOUT Cxbladder®
Cxbladder® is a non-invasive, accurate test that enables the early 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 completed multi-centre international clinical study recruited 467 patients from Australia and New Zealand. Results show that Cxbladder® outperforms all of the benchmark technologies in the trial and detected nearly all of the tumours of concern to a urologist; greater than 95% of all late stage and high grade tumours.

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 2x incidence of bladder cancer over non fire fighters. Smoking is a significant contributing factor (over 50% in males and 33% in females, approximately 1 of every 2 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, chemical engineers. Finally, 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 70% with 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.

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