Cxbladder Monitor to replace cystoscopy in clinical evaluation for low risk surveillance patients

Cancer diagnostics company, Pacific Edge Limited (NZX:PEB), has received approval for its latest Cxbladder diagnostic technology, Cxbladder Monitor, from Waitemata District Health Board (WDHB) through the national procurement services of healthAlliance.

Under the WDHB program, selected low risk patients who are undergoing routine surveillance following a previous diagnosis and treatment for bladder cancer will receive a Cxbladder Monitor test. If the test rules out bladder cancer, it means these patients will not require a clinic appointment or have to undergo an invasive cystoscopy procedure.

Brent Pownall, Commercial Director of Pacific Edge Diagnostics, said: “This is another significant achievement for Pacific Edge. To have our newest product, Cxbladder Monitor, adopted so readily at Waitemata DHB, and patients to potentially be spared from undergoing a cystoscopy, is huge. The positive impact of this initiative, demonstrated by the urology team at North Shore Hospital in changing their approach to managing this group of surveillance patients, cannot be underestimated.”

Dr Madhu Koya, Clinical Director of Urology at Waitemata DHB said: “The approach we are taking with Cxbladder is about ensuring that we deliver the best possible care for our patients and clients, living our values of compassion, connectedness, continuous improvement and leadership. In this case, we have adopted the cutting edge Cxbladder Monitor test to improve the lives of some of our bladder cancer surveillance patients with this simple to use, non-invasive urine test. This avoids the inconvenience and anxiety of a visit to the hospital clinic, and the invasive cystoscopy that goes with it, and provides the peace of mind that there is no recurrence of the disease. This is all about what is best for the patient.”

“We have been involved in the clinical evaluation of the Cxbladder products over a number of years. We trialled Cxbladder Monitor with patients and in our clinics soon after it launched and quickly recognised its utility in allowing us to change how we manage our low risk bladder cancer patients for follow up, while at the same time improving their care with this convenient urine test,” Dr Koya said.

Cxbladder Monitor, which was launched in New Zealand in December 2015, combines both genotypic biomarkers from a small quantity of a patient’s urine and patient clinical information to accurately identify those patients who have a low probability of having recurrent urothelial carcinoma (UC), or bladder cancer. Results from clinical trials showed a high test sensitivity and high negative predictive value for Cxbladder Monitor, required to accurately rule out a recurrence of UC. The initial trial results also demonstrated superior performance over all other urine-based tests and were presented at the American Urological Association's 2016 Annual Meeting in May, in San Diego, CA.

CEO of Pacific Edge, David Darling, commented: “This highlights the value in our approach to developing a suite of Cxbladder products that address multiple needs across the entire diagnostic, treatment and management pathway for bladder cancer. Pacific Edge now has all of its current Cxbladder tests being deployed in a wide variety of clinical settings, and in multiple markets – the company is now truly a ‘one stop shop’ of bladder cancer detection and management tests.”