Dunedin cancer test gets the edge in $7b market

A small Dunedin company is about to launch a world-first medical test that will make diagnosis of bladder cancer quicker and less invasive for patients, and potentially save million of dollars in treatment costs.

Pacific Edge Biotechnology Ltd, which employs just 16 staff, has developed a test that diagnoses bladder cancer by analysing just 2 millilitres of urine.

The development of the test represents a vast international opportunity. Pacific Edge estimates the global market for such early detection is worth more than $7 billion.

Its bladder cancer test can determine whether a patient has a superficial tumour or an invasive cancer. These results then determine the best course of treatment. At the moment the most accurate test for the cancer involves inserting a fibre optic tube into the bladder via the urethra and taking tissue samples.

Pacific Edge CEO David Darling said his company's test can replace the need for that kind of testing by capturing the ribonucleic acid in a patient's urine that has been produced by the tumour cells. "The key is that urine is in constant contact with the tumours."

Darling says bladder cancer incurs the highest medical costs of any cancer. Without an easy early detection test, there can be long waits between a patient consulting their doctor after discovering blood in their urine and an appointment with a urologist.

The normal procedure is for GPs to arrange tests. Depending on the result, a patient will then be referred to a specialist for further tests.

"The waiting time is about four weeks, which is a problem because it is quite a progressive disease with a high recurrence rate."

There are about 3000 new cases of bladder cancer in Australia and New Zealand each year. In the US there are 67,000 new cases a year, and testing costs reach $1 billion annually – a figure Darling said his test could slash by about 30 percent.

The test will be unveiled at a urology conference in Perth in February. Pacific Edge is also building a laboratory in Dunedin to process the tests.

It has taken six years from identifying the need for the test to product development and Darling said the results of clinical trials in New Zealand, Australia and Russia are just weeks away from being finalised. He said the most important component that had already been proven during the research phase was the test's accuracy.

The measures for accuracy were sensitivity – the ability to capture everyone who has the disease – and specificity, which is the ability to exclude the disease if it is not present. Research on the Pacific Edge test has produced a 90 percent accuracy rating on sensitivity and 85 percent on specificity, which Darling said offered a high degree of scientific credibility.

The company is also developing other cancer diagnostic and prognostic tests, including those for gastric cancers and stage three melanoma.

The melanoma test, being developed in conjunction with an Australian research institute, assesses the degree of aggression in tumours, which then determines treatment, which Darling said could make a big difference for patients.

"If there is a low risk of aggression there is no need for excessive chemotherapy."

Darling said the company could have licensed the test to laboratories around the world, but preferred to retain control. "We want the technology to be retained in New Zealand and are very proud to have developed it here," he said.