Cxbladder Monitor was Pacific Edge's third test in its Cxbladder suite of accurate and non-invasive bladder cancer diagnostic tests. It had been designed to be used on patients as part of their ongoing surveillance regime to quickly and accurately identify those who had a low probability of having recurrent cancers.
Publication of a paper confirming the superior performance of Cxbladder Monitor in ruling out the recurrence of bladder cancer was recently accepted for publication by the Journal of Urology, providing the momentum to launch the new product in the US, he said.
The test had been commercially available in New Zealand since December last year and was recently adopted by Auckland's Waitemata District Health Board for patients undergoing routine surveillance for bladder cancer recurrence.
''We are very excited about Cxbladder Monitor's launch in the US.''
The Monitor joined Pacific Edge's two other products - Cxbladder Triage, which helped to rule out cancer in patients who had a low probability of having bladder cancer, and Cxbladder Detect, which was used specifically to detect bladder cancer, Dr Darling said.
The Monitor provided a way to identify patients who had a low probability of bladder cancer recurrence. The patients might not need a cystoscopy or other invasive work-up or could increase the intervals between invasive work-ups, reducing costs and improving quality of life.
More than seven million people in the US presented annually with hematuria (blood in urine). Bladder cancer was the fifth-most prevalent cancer in the US and had a recurrence rate of up to 70%.
Many people could be monitored for most of their life with expensive and invasive tests. As a result, it had the highest total medical costs of any cancer over the lifetime of the patient, he said.
This year, Pacific Edge entered into contracts with the Veterans Health Administration and Tricare Health Plan Network. Between them, those two programmes provided cover to about 13 million US veterans, active military personnel and their families.
A fourth Pacific Edge test product was expected to be released next year.
