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Commercial agreement for entry of Cxbladder to DHBs

10 February 2014
Health Innovation Hub signs commercial agreement for entry of Cxbladder to DHBs

The Health Innovation Hub (HIH) has signed a commercial agreement to engage District Health Boards in the adoption of Pacific Edge’s non-invasive bladder cancer detection system Cxbladder, making it accessable for nearly one out of every two New Zealanders.

As a result of the agreement Cxbladder will be considered for use to evaluate patients presenting with haematuria, a symptom of possible bladder cancer, in clinics operated by the four largest District Health Boards (DHBs), Auckland, Waitemata, Counties Manukau and Canterbury.

The HIH is a recently formed government enterprise with a mandate to enable technology commercialisation into and out of the country’s four largest DHBs.

Pacific Edge Chief Executive Officer David Darling says the agreement with HIH is especially poignant.

“Cxbladder has been clinically tested in some of these DHBs, in conjunction with their respective urologists who work in both the public arena and private practice. The decision of HIH to now assist the adoption of Cxbladder is a strong endorsement of its ability to deliver sound clinical outcomes for patients and significant savings in time and expense for DHBs.”

Cxbladder has recently also completed a blinded User Program in both Waitemata and Canterbury DHBs with outstanding results validating Cxbladder in these clinical settings.

“It was particularly pleasing to see such great results from these blinded studies, confirming the outcome of the large clinical study published in the Journal of Urology in the United States in September 2012,” says David Darling.

The Health Innovation Hub Chief Executive Officer Frances Guyett says identifying and forming strategic relationships with key external partners to accelerate commercialisation by enabling access to DHBs is one of the HIH’s key objectives.

"Pacific Edge is an innovative New Zealand company with demonstrated export potential. The Health Innovation Hub is passionate that New Zealanders should benefit from access to the same innovative health products that international markets do. Cxbladder is an exciting innovation with the potential to bring benefits to millions of people who show the symptoms of or need monitoring for bladder cancer.”

The agreement with HIH builds on a momentous 12 months for Pacific Edge. During 2013 the Dunedin-based cancer diagnostic company attained regulatory approval from CLIA, for both the Dunedin commercial laboratory and its purpose built Cxbladder testing laboratory in Hershey, Pennsylvania. In the United States, the world’s largest healthcare market, Cxbladder has been commercially launched, achieved sales and signed agreements with several large national provider networks to give more than 50 million Americans access to the bladder cancer diagnostic system. Other milestones included an agreement with Mid Central DHB based in Palmerston North to use Cxbladder to evaluate patients presenting with haematuria.

Cxbladder detects nearly 100 per cent of urothelial carcinomas, in preference to cytology for the detection and monitoring of patients who may have bladder cancer.

Pacific Edge Chief Executive Officer David Darling says the Government must be congratulated for creating the Health Innovation Hub in 2011 as a catalyst for the commercialisation of new innovative medical technologies coming from, and entering the health technology sector. There are a number of significant changes taking place in the procurement and adoption of step-change technology in the healthcare system New Zealand and part of those changes is a more expedient process for adoption of technology that will lower cost and or improve patient outcomes.

“New Zealanders will be the real winners of this initiative. Half the population are now able to more expediently access Cxbladder technology providing a highly accurate and efficient alternative to the other diagnostic techniques now commonly used. The option of patients being able to give a urine sample at home and for clinicians to receive the results a few days later has the potential to offer DHBs significant cost benefits by reducing the number of patients requiring a full clinical work-up.”

In addition to Pacific Edge's own subsidiaries offering Cxbladder in the United States and NZ, Cxbladder is being marketed in Australia by Healthscope, a leading healthcare provider, and is due to be launched in Spain, which has one of the highest incidences of bladder cancer, this year.


Editor’s note: The combined population of Auckland, Waitemata, Counties Manukau, Canterbury and Mid Central DHBs is 2.208 million – source DHB websites

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.
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.

ABOUT Cxbladder
Cxbladder is 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 is commercialised in the USA 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.
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 New Zealand Health Innovation Hub
The New Zealand Health Innovation Hub’s purpose is to build a healthier world through smart innovation by becoming a world leader in accelerating health-related innovations from ideas to market through the establishment and on-going development of strategic partnerships, accelerateing product and service realisation, and leveraging the capilities and resoureces within the public healthcare sector and particpating DHB’s to optimise healthcare benefits.

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