- Release Date: 07/05/15 15:08
- Summary: GENERAL: PEB: Cxbladder Detect favourable comparison
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PEB 07/05/2015 15:08 GENERAL PRICE SENSITIVE REL: 1508 HRS Pacific Edge Limited GENERAL: PEB: Cxbladder Detect favourable comparison 7 May 2015 Cxbladder Detect favourable comparison with a leading bladder cancer detection product, UroVysion FISH, to be published Dunedin-based Pacific Edge announces a breakthrough by demonstrating its pre-eminent status as a bladder cancer diagostic in a science paper accepted for publication by medical journal BioMed Central ("BMC") Medical Research Methodology. The science paper describes the clinical performance of Cxbladder Detect compared with a variety of bladder cancer diagnostic products currently in use, using a uniquely developed mathematical imputation. BMC is a Science, Technology and Medicine publisher of 276 peer-reviewed open access journals. The journal views open access to research as essential in order to ensure the rapid and efficient communication of research findings. Publication is expected in early June after acceptance was granted for the publication of this novel approach to comparative analysis of bladder cancer diagnostics. Pacific Edge Chief Executive Officer David Darling says: "This is the second publication by Pacific Edge in the peer reviewed BMC journal within 2 months. This publication is especially relevant for the US healthcare providers and payer organisations who prescribe and pay for such advanced diagnostic tests. It is a key element in our strategy of making Cxbladder Detect widely available in the USA this year." "This paper which is based on a large set of data from 5 clinical trials shows that the Cxbladder Detect test outperforms a number of competing bladder cancer diagnostic tests, including UroVysion FISH which is available primarily in the US. This finding favourably positions Cxbladder Detect as the leading bladder cancer diagnostic in terms of its relative performance," says David Darling. The paper is based on a series of novel mathematical approaches that allowed comparison of data from sources where not all tests had been carried out. The approach made it possible to estimate missing data, hence very powerful comparisons could be made across all the data sets that would not otherwise have been possible. All of the approaches used in the analysis demonstrated the superiority of Cxbladder Detect as a diagnostic for bladder cancer. The Chief Execitive Officer for Pacific Edge Diagnostics USA, Jackie Walker, says:"Not only does this publication provide further evidence of the superior sensitivity of Cxbladder Detect in diagnosing bladder cancer compared other other non-invasive tests, but most importantly it is the first piece of comparative data that includes UroVysion FISH, a molecular test that is widely used by clinicians and physicians in the US. As we expected, Cxbladder Detect proved to be better at detecting bladder cancer than all the non-invasive tests currently being used in the US and provides an effective adjunt to cystoscopy, and this is what clinicians have been looking for." Pacific Edge CEO, David Darling says: "This publication will add a key piece of ammunition to Pacific Edge's clinical dossier, supporting our case to secure a positive local coverage determination (LCD) for reimbursement by the Center for Medicare and Medicaid Services (CMS) as well as other commercial payers." For more information contact: David Darling Chief Executive Officer Pacific Edge Ltd P: +64 (3) 479 5800 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. The company is developing and commercialising its range of Cxbladder bladder cancer tests. It's first commercial product, Cxbladder Detect, is now being actively marketed to physicians and clinicians in New Zealand, Australia, and the USA through the company's wholly owned subsidiaries and selected commercial partners. www.pacificedge.co.nz www.pacificedgedx.com ABOUT Cxbladder Detect Cxbladder Detect 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 Detect is commercially available in New Zealand, Australia and the USA. Cxbladder Detect is available in the USA and NZ as a laboroatory Developed Test (LDT) from the company's CLIA certified laboratories, providing 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 Detect cancer detection test has been validated by a multicentre, international clinical study. www.cxbladder.com ABOUT Cxbladder Triage Cxbladder Triage is a novel molecular test that combines the power of the genomic biomarkers with extra phenotypic biomarkers to accurately identify and remove patients with haematuria who have a low probability of bladde cancer, from needing to have a full-urological work-up. This is a tool for use by clinicians and physicians in the primary evaluation and will result in a reduction of the number of patients needing an expensive and invasive work-up for urothelial cancer. 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. Bladder cancer has a very high recurrence rate of approximately 50%-70% with up to 30% of these recurring as later stage tumours. However, bladder cancers are highly treatable, especially if detected in the early stages when there is a much higher probability of survival. Timely detection and regular surveillance and monitoring of this cancer is a key element of the clinical process and of the individual's annual healthcare plan. End CA:00264068 For:PEB Type:GENERAL Time:2015-05-07 15:08:16
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