Cxbladder™ Boosting Confidence in Bladder Cancer Detection in the US
Posted on January 29th, 2014
New, urine based test offers patients greater peace of mind from accurate, reliable results.
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 America’s Choice Provider Network to expand access to Cxbladder in the US
2. First Commercial Sales Achieved for Pacific Edge’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
2“Bladder Cancer Facts.” Bladder Cancer Advocacy Network. Accessed 1/22/14
Tan Tock Seng Hospital User Program for Cxbladder Cxbladder™ Boosting Confidence in Bladder Cancer Detection in the US Pacific Edge signs Cxbladder™ agreement with third national provider network in the US Pacific Edge signs agreement with America’s Choice Provider Network to expand access to Cxbladder in the US Cxbladder is Supreme Winner at NZ Innovators Awards First Commercial Sales Achieved for Pacific Edge’s Cxbladder in the USA Pacific Edge Agreement With National Provider Network FedMed Gives 40 Million Americans Access to Cxbladder Cxbladder excels in New Zealand MidCentral DHB first in New Zealand to utilise Cxbladder Pacific Edge's US laboratory receives CLIA registration for Cxbladder NZTE Video: David Darling discusses roll-out of Cxbladder in the US Cxbladder mentioned in Sir Peter Leitch's Newsletter Health Innovation Hub signs commercial agreement BOP and Lakes Urologists adopt Cxbladder Callaghan Innovation Growth Grant accelerates Cxbladder development Pacific Edge signs Cxbladder agreement with MultiPlan Pacific Edge to launch New Zealand e-commerce site for bladder cancer testing service Cxbladder testing service e-commerce site goes live in New Zealand Cxbladder User Program research agreement signed with Kaiser Permanente Southern California Pacific Edge Launches Cxbladder Triage Cxbladder Triage To Be Showcased In Prestigious Medical Journal Cxbladder Triage paper published in international medical journal Private Insurance Coverage Confirmed for Cxbladder Pacific Edge is successful in obtaining ISO accreditation Cxbladder Detect favourable comparison with a leading bladder cancer detection product, UroVysion FISH, to be published Research Shows Pacific Edge’s Cxbladder Detect Outperforms Other Non-Invasive Bladder Cancer Diagnostics Patient Community Connecting People Living with Bladder Cancer Pacific Edge Presents Positive Cxbladder Monitor Results Pacific Edge and Cxbladder in USA Today