- Release Date: 02/10/13 14:02
- Summary: GENERAL: PEB: US accolade - accreditation granted to Pacific Edge NZ lab
- Price Sensitive: No
- Download Document 6.55KB
PEB 02/10/2013 11:02 GENERAL REL: 1102 HRS Pacific Edge Limited GENERAL: PEB: US accolade - accreditation granted to Pacific Edge NZ lab 2 October 2013 US accolade with accreditation granted to Pacific Edge NZ Laboratory Cancer diagnostic specialist Pacific Edge has joined an elite group of organisations outside the United States with the registration of Pacific Edge Diagnostics' Dunedin laboratory to conduct Cxbladder tests under the CLIA regulatory process. CLIA registration is mandatory for any laboratory processing Laboratory Developed Tests (LDT) with samples originating from patients within the United States or its territories. Pacific Edge Chief Executive Officer, David Darling, says registration of the Dunedin laboratory complements the Company's purpose built and CLIA registered facility at Hershey, Pennsylvania in the USA. There are several advantages that arise; first, that this level of accreditation for a New Zealand laboratory enhances the overall quality of professional service and quality practiced on our bladder cancer tests and secondly we now have a high quality back-up facility operating at international standards for our global business. "If, for example, there is any major environmental issue in the United States that disrupts operations at the Hershey laboratory, we can now provide clinicians and patients there the security of still delivering test results promptly. This is a further significant step for Pacific Edge in the commercialisation of Cxbladder. The CLIA regulatory registration of the Dunedin laboratory has eliminated a major strategic risk from our business. It also provides the Company with additional flexibility as the demand for Cxbladder builds in the United States." The Dunedin laboratory also has the capacity to cope with any unexpected surge in the demand for Cxbladder tests beyond Hershey's capability of processing up to its design capacity of approximately 4,000 tests per week. Cxbladder is a quick, cost effective, non-invasive and highly accurate diagnostic test that enables clinicians to detect urothelial carcinomas including cancers of the bladder. The Company's Hershey based laboratory gained CLIA registration in March 2013 enabling Pacific Edge to launch Cxbladder commercially in the United States in July. Currently, the Dunedin laboratory processes samples obtained from patients in New Zealand as well as all samples for clinical or in market studies and User Programmes. CLIA or the Clinical Laboratory Improvement Amendments sets standards and issues certificates for clinical laboratory testing of Laboratory Developed Tests (LDT) in the United States. It is administered by the US government agency, Centre for Medicare and Medicaid Services, CMS. Only one other laboratory in Australasia is understood to have CLIA registration with most CLIA registered laboratories operating in the United States and its associated territories. 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. 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 soon to be Spain and the US. 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 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 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. End CA:00241888 For:PEB Type:GENERAL Time:2013-10-02 11:02:08
Add to My Watchlist
What is My Watchlist?
