Cxbladder Boosting Confidence in Bladder Cancer Detection in the US

HERSHEY, PA - Bladder cancer patients, survivors, and families faced with life-long surveillance of the highly recurring disease are finding reassurance in Cxbladder. This new, non-invasive, urine based bladder cancer detection test developed by Pacific Edge Ltd 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.

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 offers patients a non-invasive, accurate test for the detection of bladder cancer. This test is available from Pacific Edge in several countries around the world and is now available in the US from Pacific Edge's new, dedicated CLIA laboratory and commercial headquarters in Hershey, Pennsylvania.

"I have been using Cxbladder extensively since June 2011. 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." says Dr. Joe DiTrolio, a Board Certified Urologist, Professor of Surgery, Section of Urology/Department of Surgery Rutgers New Jersey Medical School.

Cxbladder is being utilized by clinicians 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 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 was been 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", says Dr. Guy Bernstein, 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", says Jackie Walker, CEO of Pacific Edge Diagnostics USA. "We are committed to fighting this disease, and early and accurate detection is a key part of that."

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.

Recent news links:
1. Pacific Edge Agreement with National Provider Network FedMed Gives 40 Million Americans Access to Cxbladder; Pacific Edge signs agreement with Americaäó»s Choice Provider Network to expand access to Cxbladder in the US
2. First Commercial Sales Achieved for Pacific Edgeäó»s Cxbladder in the USA

Patient education materials about Cxbladder are available at 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: www.cxbladder.com.

¹O'Sullivan et al; Journal of Urology September 2012

²Bladder Cancer Facts.äó Bladder Cancer Advocacy Network. Accessed 1/22/14