Health Minister Tony Ryall Opens Leading Cancer Centre

NZX ANNOUNCEMENT 24th MAY 2011

Health Minister Tony Ryall Officially Opens World Leading Cancer Diagnostic Centre

The battle against cancer took a further step forward today with the official opening of a specialist diagnostic laboratory for Dunedin-based Pacific Edge by the Minister of Health, the Hon Tony Ryall.

The purpose built facility for Pacific Edge’s subsidiary Pacific Edge Diagnostics Limited will perform the novel cancer detection test for bladder cancer developed by the group’s research team. With the opening of New Zealand’s first purpose built laboratory for the detection of bladder cancer, using the Cxbladder® product, Pacific Edge Diagnostics is now engaged in the commercial release of the Cxbladder® product to clinicians in Australia, New Zealand, Spain and Portugal. Pacific Edge Chief Executive Officer David Darling says the opening of the facility is a significant milestone for the company’s staff, shareholders and bladder cancer patients.

“The scientific and commercial advances being made by Pacific Edge to develop highly accurate diagnostic and monitoring tools for cancer will potentially have a dramatic impact on the lives of many thousands of people each year by allowing clinicians to better diagnose and manage cancer”.

“Cxbladder®, the company’s first product, is a non-invasive test of a small sample of the patient’s urine, used to diagnose bladder cancer earlier and less invasively. Bladder cancer is the ninth most prevalent cancer in the world and the fourth most common for men. Those diagnosed with bladder cancer usually have to undergo regular testing for up to five years to monitor for return of the disease. The simplicity, accuracy and non-invasive nature of Cxbladder® will be particularly attractive for clinicians and patients alike.”

“This is the third major achievement announced by the company in the last few months and builds on the extensive research work undertaken by our dedicated scientific and management team over the last 9 years.

Agreements for the company’s first commercial cancer diagnostic test, Cxbladder®, for detecting the presence of bladder cancer, have been put in place with Australia’s leading healthcare group Healthscope, and, with today’s announcement, in Spain (see separate release) with biotechnology and molecular diagnostics company Oryzon.

“We welcome the Minister of Health, the Hon Tony Ryall, to mark this step forward for the company and for the ongoing fight against cancer, by officially opening Pacific Edge’s laboratory. This facility will be the model used in the commercialisation of other products in development by the company going forward.”

The advanced laboratory is equipped with a specialised information management system (LIM) designed to communicate to and integrate with the laboratory systems of Pacific Edge’s commercial partners around the world. The system also manages the laboratory’s complex equipment such as the robotic liquid handling system and Roche Diagnostic’s quantitative PCR machines and provision of the individual patient reports to clinician customers. The laboratory is in the process of completing ISO 15189 accreditation, which is the internationally recognised hallmark of quality management systems for medical laboratories and will join the recent registration of the Cxbladder® sample kit with the Therapeutic Goods Administration (TGA) in Australia and the European Conformity (CE) mark in Europe.

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 the cancer with the ninth highest incidence, bladder cancer is the fourth highest for men. One of the early symptoms of bladder cancer is the presence of blood in the urine, haematuria. People with haematuria present to their general practitioner before being referred to a urologist. Treatment of bladder cancer incurs the highest total medical costs of any cancer, and in the United States this figure is approaching US$200,000 per patient from detection until death. In Australia there are expected to be in excess of 50,000 people presenting to their healthcare provider this year with blood in their urine, often a precursor to bladder cancer, and it is anticipated that the Australian healthcare system could invest in excess of $50 million per annum in investigating haematuria. Cxbladder® is expected to completely replace cytology and be used to complement cystoscopy in the clinical care path for patients presenting to clinicians with haematuria.

Pacific Edge Limited (NZX: PEB)

Pacific Edge (PE) is a New Zealand based biomedical and diagnostics 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, endometrial cancers and melanoma. The company has recently completed and released its first product for the detection of bladder cancer, Cxbladder®.

ENDS

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