- Release Date: 10/09/13 13:14
- Summary: GENERAL: PEB: Cxbladder excels in New Zealand
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PEB 10/09/2013 11:14 GENERAL REL: 1114 HRS Pacific Edge Limited GENERAL: PEB: Cxbladder excels in New Zealand 10 September 2013 Cxbladder excels in New Zealand New Zealand clinicians and healthcare providers are excited about Pacific Edge Limited's cancer detection system Cxbladder for its ability to detect bladder cancer with a high degree of accuracy. Two User Programmes in New Zealand - a combined study of 178 patients with macro-haematuria (blood in urine) has found that Cxbladderdetect outperforms cytology and saw 90% of all tumours. The full results are being prepared for publication. The User Programme studies were conducted at two centres by Tony Beaven and Sue Osborne in conjunction with the Waitemata District Health Board (DHB); and Nick Buchan, Peter Davidson, Liz Mitchell and Barbara Gordon of Canterbury Urology Research Trust in conjunction with Canterbury DHB. The study confirms the results of a larger, multi-centre Australasian study published last September in the peer reviewed Journal of Urology in the United States where Cxbladder outperformed the other commercially available tests benchmarked in the study. In that large study at a specificity of 85% Cxbladderdetect saw 100 % of T1, 100% of T2, 100% of T3, 100% of Tis and 100% of upper urinary tract cancers. Cxbladderdetect also saw 97% of high grade tumours. Pacific Edge's Commercial Manager, Brent Pownall, says the New Zealand user study demonstrates that Cxbladderdetect is a highly accurate and efficient detection test for urothelial carcinomas in the New Zealand healthcare context. "We look forward to having this product more widely used in New Zealand's healthcare programmes, thus benefiting DHBs, clinicians and patients alike." "Cxbladderdetect gives clinicians and patients a high degree of assurance that the results are accurate which cytology cannot achieve to the same degree. In combination with cystoscopy, Cxbladderdetect will provide significant clinical upside, benefiting both patients and clinicians." "Patients presenting with haematuria who are given the choice of providing a urine sample for Cxbladderdetect, or undergo an extensive work-up and experience the discomfort of cystocopy, are likely to choose Cxbladderdetect every time." For our DHBs which are focused on providing the very best cost effective healthcare for New Zealanders, Cxbladderdetect provides a number of significant advantages: oThe Urine Sampling System can be sent directly to the patient at home, thereby minimising the need to queue to see a specialist and the inconvenience of another trip to the doctor or pathology lab collection centre oCxbladderdetect provides a cost effective way of evaluating patients presenting with haematuria before they get to the clinic and oCxbladderdetect does it in a non-invasive way. Mid Central DHB based in Palmerston North is underway with their programme targeting Cxbladderdetect for yet another clinical value proposition that is expected to see a proportion of patients with haematuria, not having to come into the clinic for a full work-up. Paul O'Sullivan, Pacific Edge's Clinical Science Manager, outlined that the User Programme studies for Waitemata and Canterbury are based on 178 patients presenting with haematuria undergoing investigations for possible urothelial carcinomas. All were tested using Cxbladderdetect as part of their clinical work-up. Results of the Cxbladderdetect test were compared with urine cytology and cystoscopic findings to determine the clinical utility of the Cxbladderdetect test. "Cxbladderdetect proved its superiority over cytology by a wide margin in detecting 90% of the cases of urothelial carcinomas amongst the 178 patients. On one site Cxbladderdetect correctly detected 100% of the patients with urolthelial carcinoma. It also demonstrated its ability to correctly screen out patients who did not have urothelial carcinomas, which the study noted was particularly beneficial in patients presenting with haematuria." The study results will be published by way of a presentation at the Urological Society of Australia and New Zealand (USANZ) Annual Scientific Meeting in March 2014. For further information please contact David Darling Chief Executive Officer Pacific Edge Limited P: +64 (3) 4795800 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 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 USA and soon to 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 Limited and Pacific Edge Diagnostics USA Limited, and selected commercial partners in Australia and Spain, Healthscope Pathology and Oryzon respectively. www.pacificedgedx.com 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 published, Journal of Urology in September 2012, multi-centre international clinical study recruited 485 patients from Australia and New Zealand. Results show that Cxbladder out-performed all other benchmark technologies in the clinical trial and detected nearly all of the tumours of concern to a urologist; At 85% specificity, the test sees 100% of T1, T2, T3, Tis and 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. End CA:00240937 For:PEB Type:GENERAL Time:2013-09-10 11:14:10
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