HERSHEY, Pa., Jan. 29, 2014 /PRNewswire/ -- Bladder cancer patients, survivors, and families faced with life-long surveillance of the highly recurring disease are finding reassurance in Cxbladder, a new bladder cancer detection test developed by Pacific Edge Ltd. This non-invasive, urine-based test measures the expression of five genes that create a unique molecular signature for bladder cancer, alerting doctors to possible tumors. More accurate1 than many other urine-based cancer detection tests, Cxbladder can give patients and doctors added confidence in their diagnoses.
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Bladder cancer has a very high rate of recurrence and often progresses quickly. Consequently bladder cancer patients live in a world of ongoing monitoring and clinical intervention, much of it is invasive and expensive. Cxbladder, previously available in several countries around the world from Pacific Edge, offers patients a non-invasive, accurate way to detect bladder cancer. Now, Cxbladder is available in the in the United States from Pacific Edge's new, dedicated CLIA laboratory and commercial headquarters in Hershey, Pennsylvania.
"I have been using Cxbladder extensively since June 2011," said Joe DiTrolio, M.D., a Board Certified Urologist and Professor of Surgery, Section of Urology/Department of Surgery, Rutgers New Jersey Medical School. "Over that time period, Cxbladder has proven to be the most accurate, non-invasive test for monitoring patients with either hematuria or known bladder cancer."
Clinicians are using Cxbladder to provide a number of clinical and patient advantages. The test can be used on patients presenting with hematuria to rule-in or rule-out the presence of bladder cancer, saving many patients the inconvenience, invasiveness and cost of a full urological workup.
Researchers at Pacific Edge have found that messenger RNA (mRNA) levels of specific biomarker genes are typically present at higher levels in urine samples of patients that are positive for bladder cancer compared to urine samples from patients who are negative for the disease.
The performance of the Cxbladder test was evaluated in a formal clinical study and published in the Journal of Urology in 2012. The study shows that Cxbladder outperformed all of the other clinical technologies that were evaluated alongside it. In this study1, Cxbladder correctly identified 100% of late stage tumors and 97% of high-grade tumors.
Just a small sample of urine is required for the test. Patient samples are collected in an easy, simple to use urine sampling system, analyzed at Pacific Edge Diagnostics' CLIA-certified and CAP-accredited laboratory in Hershey, Pennsylvania, and the results are sent to the physician within seven business days.
"The Cxbladder test is a wonderful new diagnostic tool in our evaluation process for patients with new onset hematuria and for patients who are being followed with known bladder cancer," said Guy Bernstein, M.D. a Board Certified Urologist at Urology Health Specialists in Bryn Mawr, PA.
Cxbladder is a quick, cost effective, non-invasive, accurate cancer detection test that has significant advantages to both patients and healthcare providers said Jackie Walker, Chief Executive Officer of Pacific Edge Diagnostics USA. "We are committed to fighting this disease, and early and accurate detection is a key part of that effort."
More than seven million Americans will have some form of blood in their urine (hematuria) resulting in more than one million undergoing evaluation this year for bladder cancer. It is estimated that 1 in 42 Americans will develop bladder cancer in their lifetime2. The very high recurrence of this disease following a positive diagnosis requires some patients to receive expensive monitoring for the rest of their lives. Bladder cancer has the highest total medical costs of any cancer per patient. Nearly $3 billion is spent to treat bladder cancer each year in the US.
Patient education materials about Cxbladder are available at http://www.cxbladder.com. Pacific Edge also offers a Patient Financial Assistance Program to ensure access to this cutting edge test.
For more information about Cxbladder, contact Customer Service at Pacific Edge Diagnostics USA Ltd. at 1-855-CXBLADR (1-855-292-5237) or visit the website: http://www.cxbladder.com .
REFERENCES
1 O'Sullivan et al; Journal of Urology September 2012
2 "Bladder Cancer Facts." Bladder Cancer Advocacy Network. Available online: http://www.bcan.org/facts/ Accessed 1/22/14
ABOUT PACIFIC EDGE LTD
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic company specializing in the discovery and commercialization 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 characterization 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 the United States, New Zealand, Australia, and soon to be in Spain.
www.pacificedge.co.nz
ABOUT PACIFIC EDGE DIAGNOSTICS USA LTD
Pacific Edge Diagnostics USA LTD is a subsidiary of Pacific Edge Limited, a cancer diagnostics company specializing in the discovery and commercialization of diagnostic and prognostic technology for the early detection and monitoring of cancer. Pacific Edge provides centralized diagnostic services through its facilities in the US and New Zealand. Pacific Edge products are based on proprietary genetic databases used to identify diagnostic biomarkers for cancers.
Contact:
Jackie Walker
1214 Research Blvd., Suite 2000
Hummelstown, PA 17036
www.cxbladder.com
Phone: (717) 220-7005
jackie.walker@pacificedgedx.com
SOURCE Pacific Edge Diagnostics USA LTD