Cxbladder Monitor shows superior performance in ruling out recurrence of bladder cancer

The prestigious American Journal of Urology has accepted for publication a paper confirming the superior performance of Pacific Edge’s Cxbladder Monitor test for the surveillance of bladder cancer recurrence, offering patients with bladder cancer the potential utility of avoiding or deferring some cystoscopies.

Titled “Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study”, the paper validated the performance of Cxbladder Monitor as a high-sensitivity urine test for ruling out the presence of urothelial carcinoma (bladder cancer) during routine surveillance for recurrence of the disease.

Specifically, the paper found that the Cxbladder Monitor test demonstrated high test sensitivity (93%) and high negative predictive value (97%) which provide physicians with actionable results and a high level of certainty when looking to rule out bladder cancer recurrence.  Using Cxbladder Monitor as a confirmatory negative adjunct to cystoscopy, or to justify postponing future cystoscopic investigations in select patients offers significant clinical utility.

The paper noted that the high performance of Cxbladder Monitor was independent of patient demographics, tumour stage and grade, and regardless of whether or not patients had undergone BCG treatment.

The paper concluded that Cxbladder Monitor provides clinicians with a greater degree of certainty when monitoring for recurrent bladder cancer, or as a direct rule-out test for patients identified as being at low risk for recurrent disease, thereby avoiding cystoscopies in patients with a negative Cxbladder Monitor result.

Chief Executive Officer of Pacific Edge, David Darling, commented: “Cxbladder Monitor provides an opportunity to enhance the standard of care for bladder cancer patients, making monitoring of this disease more effective and importantly for the patient, less invasive. The test shows a high level of performance and is particularly robust in monitoring patients undergoing surveillance. The addition of Cxbladder Monitor to our portfolio supports our strategy to provide a ‘one stop shop’ of bladder cancer products designed to meet different clinical needs.”

The peer reviewed scientific paper will shortly be available online at the Journal Of Urology website and will be published in a subsequent print edition of the Journal, which is circulated to over 22,000 members of the American Urological Association, with the product launch process currently underway in the USA.

Cxbladder Monitor was launched in New Zealand in December 2015, and was recently adopted by Auckland’s Waitemata District Health Board for patients undergoing routine surveillance for bladder cancer recurrence. It is Pacific Edge’s third cancer diagnostic test, as the company continues to build its suite of simple, accurate and non-invasive cancer diagnostic tests. Cxbladder Triage helps to rule out cancer in patients with haematuria (blood in the urine) who have a low probability of having bladder cancer; Cxbladder Detect is used specifically to detect bladder cancer; and Cxbladder Monitor provides urologists who are evaluating patients for the recurrence of the disease, with greater certainty of their clinical evaluations, and patients with a non-invasive way to monitor their disease.