BOP and Lakes Urologists adopt Cxbladder

11 February 2014

BOP and Lakes Urologists adopt Cxbladder

Patients presenting with symptoms of bladder cancer and those under surveillance of bladder cancer in the Bay of Plenty and Lakes District Health Board regions will now be evaluated as part of their clinical program, with Pacific Edge’s non-invasive urine sampling Cxbladderdetect test.

Bay of Plenty and Lakes District urologists are the latest to join the list of New Zealand clinicians and DHB’s who are being signed by Pacific edge Diagnostics to offer their patients Cxbladderdetect. Cxbladder is a superior technology with its ability to detect nearly 100 per cent of urinary tract carcinomas, in preference to cytology for the detection and monitoring of patients who may have bladder cancer.

Like MidCentral DHB, which began using Cxbladderdetect in June, BOP urologists will use Cxbladderdetect to evaluate patients presenting with blood in the urine (haematuria) as part of their clinical regime. This new strategy is expected to involve local GPs (the patient’s primary point of contact when symptoms occur) using Cxbladderdetect to help prioritise those patients who need to be seen urgently. They will also be able to identify low risk patients who do not require a full clinical work-up for bladder cancer, saving the public health system considerable associated expense, not to mention the inconvenience to the patients. Less than one in twenty of those patients with micro-haematuria are found to need further treatment for bladder cancer.

Pacific Edge is a Dunedin-based cancer diagnostic company leading in the development and commercialisation of molecular diagnostic tests. Pacific Edge Chief Executive Officer David Darling says there are significant potential savings to be made in the New Zealand health budget if all DHBs adopt Cxbladderdetect for the early evaluation and further analysis of patients presenting with haematuria.

“Many New Zealanders may have heard Sir Peter Leitch talk on television last year about the ease of use and high degree of confidence he and his clinician had in Cxbladderdetect for monitoring his recovery from bladder cancer”. Those benefits are now being made available to nearly half a million New Zealanders [488,280 : pop numbers from MOH website] within the BOP, Lakes regions and the Mid Central DHB.

“Cxbladderdetect will allow clinicians in these three regions to provide better clinical outcomes for patients referred for urological evaluation and contribute considerable efficiencies for patients and healthcare providers, from its use.”

Bay of Plenty urologist, Mark Fraundorfer says that now is the right time to start using Cxbladderdetect. “Pacific Edge have gathered the clinical data and published in a peer reviewed journal, and the superior performance over cytolgy is clear. BOP (and Lakes) urologists have used Cxbladderdetect in a variety of clinivcal settings in both public and our private clinics over the last nine months, confirming the performance of the technology. Cxbladderdetect provides better information about the patients being referred to urologists and allows us to increase our focus on the patients that need further evaluation and treatment, and will avoid a significant number of unnecessary procedures. This is a good outcome for both the patients and the public health system as a whole.”

A recently completed clinical user programme involving 178 patients undertaken by Waitemata District Health Board and Urology Associates in conjunction with Canterbury DHB has confirmed the successful results of a multi-centre international peer reviewed study of 485 patients published in the prestigious American Journal of Urology in September 2012. Both studies showed that Cxbladderdetect identified correctly nearly 100 per cent of tumours of concern to clinicians, including those that cytology and several that cystoscopy did not identify. The results of the two centre New Zealand user programme are expected to be formally published later this year.

For clinicians and DHBs focused on providing the very best cost effective healthcare for New Zealanders, Cxbladderdetect provides a number of significant advantages that have the potential to change clinical practice and lower the overall cost of managing the patient’s disease:

• The Cxbladderdetect Urine Sampling System (USS) can be sent directly to the patient at home or to their GP clinic, thereby reducing waiting times to see a specialist within the public hospital system.

• Cxbladderdetect provides an accurate and cost effective way of evaluating patients presenting with blood in their urine (haematuria), before they get to the clinic and

• Cxbladderdetect is non-invasive and enhances a patient’s compliance with their cancer management regime as defined by the urologist.

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.

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 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.

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.

ENDS

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