Pacific Edge today welcomes the release of new research supporting the clinical utility of the company’s genomic biomarker test Cxbladder Monitor in the surveillance for bladder cancer recurrence.

The independent study¹ is to be published in the prestigious journal Urologic Oncology and was undertaken at the University of California San Francisco (UCSF) and the University of Michigan. It examined whether a negative Cxbladder Monitor test could safely postpone a patient’s next scheduled cystoscopy, the current ‘gold standard’ for bladder cancer surveillance.

The study covered a sample of 92 US-based patients under surveillance for bladder cancer recurrence during the COVID pandemic lockdown. The patients - under the virtual supervision of their clinicians - opted to use Cxbladder Monitor leveraging Pacific Edge’s Patient In-Home Sampling System (PIHSS) as a first step to overcome pandemic-related limits on clinical evaluation slots and the risks of COVID infection during travel to and from appointments.

Of the sample, 66 patients tested negative for Cxbladder Monitor. Of those, 52 patients underwent a follow up cystoscopy, and all were tumor free – a result that supports the growing portfolio of evidence that Cxbladder Monitor can safely reduce surveillance cystoscopies without compromising cancer detection². Meanwhile, a patient satisfaction survey of those who took the Cxbladder Monitor test at UCSF revealed strong patient acceptance for the test and the PIHSS.³

The authors, while suggesting the value of further validation, said: “Cxbladder Monitor may be safely utilized to reduce the intensity of surveillance cystoscopy and appears acceptable to patients as an in-home test.”

Pacific Edge Diagnostics USA Vice President of Medical Affairs Dr Tamer Aboushwareb said: “These results represent an exciting incremental addition to the evidence supporting the clinical utility of Cxbladder Monitor in safely reducing the frequency of surveillance cystoscopy across all Non-Muscle Invasive Bladder Cancer patients and improving patient compliance.

“The sample size and the difficulties the researchers faced in following up all those patients that tested Cxbladder Monitor negative represent obvious limitations to the current study. But the absence of tumors in all patients that had a follow up cystoscopy and the strong patient endorsement of the test and our patient in home sampling system are great examples of the value of our tests.”

“We are also encouraged that the study considered patients with medical histories that broadly spanned the spectrum of recurrence risk, as defined by the American Urological Association and included both primary and recurrent tumors,” Dr Aboushwareb said.

“These results therefore further support the clinical utility of Cxbladder Monitor in diverse populations. We are looking forward to building on this study with our own clinical research program and the broad range of independent studies focused on Cxbladder taking place around the world.”

Further detail of our ongoing clinical study program can be found here.

¹ The study, “Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer”, was completed with no involvement or financial support from PEDUSA. Weblink

² Six of the 66 CxbM negative patients did not return for a follow up cystoscopy, four elected to undergo a further CxbM test rather than a cystoscopy and the remaining four patients either stopped surveillance or died of unrelated causes. Nine of the 24 patients that tested Cxbladder Monitor positive and then had an immediate clinical evaluation and cystoscopy were found to have cancer including one patient that had cancer in the upper tract.

³ 41 of the 57 patients at UCSF completed the survey and rated the PiHSS on ease of use on a scale of 1 to 5 (5 easiest) and whether they would consider using CxbM to skip cystoscopies in the future. The survey delivered a median response of ‘5’ for the first question, while 73% responded ‘yes’ to the second.