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 diagnostic 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."