Cancer diagnostics company Pacific Edge (NZX: PEB) has advised that it has successfully completed its analysis of the data from the large scale Kaiser Permanente (Kaiser) User Programme with positive and compelling findings.

The performance of Pacific Edge’s Cxbladder Triage test was evaluated in a large, blinded study (User Programme) on consenting Kaiser patients, with findings equivalent to the previously published performance for Cxbladder Triage. Kaiser is currently completing its own analysis of the data, with the joint analysis to be submitted for scientific and clinical publication.

Cxbladder Triage is designed to rule out patients who have a low risk of having urothelial cancer (bladder cancer). A previously published study on Cxbladder Triage’s performance, in the BioMed Central (BMC) Urology Journal in April 2015,  showed a sensitivity of 95.1% and a Negative Predictive Value of 98.5%, meaning that Cxbladder Triage accurately identified those patients that had a low probability of having bladder cancer and therefore did not require a full workup for bladder cancer.  

CEO and Managing Director of Pacific Edge, David Darling, said: “The positive confirmation and validation of the performance of Cxbladder Triage in the Kaiser clinical setting, where the diagnosis was blinded to us until the end of the study, is a direct reflection of the quality of the Cxbladder Triage test.

“Our analysis further validates Cxbladder’s clinical utility in haematuria and bladder cancer management and supports our goal to create diagnostic tests that are highly accurate, non-invasive, cost effective and simple to use. Cxbladder Triage can potentially save many patients from undergoing an expensive and invasive investigation for bladder cancer.”

The purpose of the User Programme was to allow Kaiser to assess the use of Cxbladder Triage in Kaiser’s own clinical settings, to effectively and accurately rule out those patients who present with haematuria¹ who have a low probability of having bladder cancer and therefore may not need a full clinical workup.

David Darling commented: “Kaiser Permanente is one of America’s largest not-for-profit health care providers, with a strong vision for improving patient outcomes. We are looking forward to working with Kaiser to scientifically publish the detailed results and negotiate a commercial relationship”.

-ENDS-

¹blood in the urine and an indicator of bladder cancer