Pacific Edge, which is based in Dunedin, has successfully competed its analysis of the data from the large-scale Kaiser Permanente user programme with ''positive and compelling'' findings.
The performance of Pacific Edge's Cxbladder Triage test was evaluated in a large, blind study on consenting patients. The findings were equivalent to the previously published performance for Cxbladder Triage, Dr Darling said when contacted.
Kaiser would now complete its own analysis of data, with the joint analysis to be submitted for scientific and clinical publication.
''This is a big outcome. This is our one transformational customer for our business. Kaiser is a big corporate entity with an emphasis on integrated healthcare.''
Kaiser ''owned'' more than 10 million patients, he said.
Asked what that meant, Dr Darling said when a patient joined Kaiser, they were provided with integrated care by the organisation.
It employed and paid its own doctors, owned its own hospitals and paid its urologists a salary. Kaiser covered its own insurance, removing the need for patients to take up options such as Medicare.
The urologists had no vested interest in what test they used for bladder cancer; they just wanted the best outcome for their patients.
Two years ago, Cxbladder came to the attention of Kaiser and the user programme had given Kaiser a chance to test it.
Pacific Edge's Cxbladder test was designed to rule out patients who had a low risk of having urothelial cancer (bladder cancer).
A previously published study on Cxbladder's performance showed a sensitivity of 95.1% and a negative predictive value of 98.5%.
That meant Cxbladder accurately identified those patients having a low probability of having bladder cancer and not requiring a full work-up for bladder cancer, Dr Darling said.
Using Cxbladder Triage would enable Kaiser to identify patients who did not have cancer, saving money by not requiring a work-up of the tests.
''This was our aha moment from a whopping big customer. Kaiser only invests long term in things that make a real difference. To carry out this test on our product was a big thing our shareholders did not quite understand. But in the US, they understand.''
If Kaiser invested in a product, usually other integrated health providers followed, he said.
The push would now come from Pacific Edge to have Kaiser validate the latest results and publish them.
One of the reasons there were no figures included in the press release announcing the deal, and why Dr Darling could not elaborate on any money deals, was the need for Kaiser to validate the results and publish.
Once the jointly-published paper was released, revenue was expected to flow to the bottom line.
''We are going to hustle to do it as quickly as we possibly can. We hope to move this along.''
Asked about what Kaiser had looked for during the tests, Dr Darling said the purpose of the user programme was to assess the use of Cxbladder Triage in Kaiser's own clinical settings.
That allowed Kaiser to effectively and accurately rule out those patients who presented with haematuria but who had a low probability of having bladder cancer and might not need a full clinical work-up.
''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 could potentially save many patients from undergoing an expensive and invasive investigation for bladder cancer.''
