This article was originally published by the Digital Journal.
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.
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.
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
SOURCE Pacific Edge Diagnostics USA LTD
