BUSINESSDESK: Dunedin-based DNA diagnostic test business Pacific Edge has received independent clinical confirmation that its bladder cancer detection test is at least as effective as other methods.

The validation in the American Journal of Urology could be worth up to $100 million a year in five years for Pacific Edge’s Cxbladder test, the company says.

Chief executive David Darling says the peer-reviewed validation that the company’s urine-based test has the ability to detect nearly all tumours of concern to urologists is very important for Pacific Edge’s US implementation strategy.

“The Journal of Urology is widely read by urologists, medical insurers and often those bladder cancer patients who are looking for an accurate, more convenient and less intrusive method of detecting bladder cancer.” 

There are 17,000 urologists in America, compared to 300 in total across New Zealand and Australia, and Cxbladder will be formally launched when its purpose-built testing laboratory in Hershey, Pennsylvania, receives certification early next year.

Mr Darling says the laboratory is close to the Pennsylvania State University Hospital, one of four integrated cancer facilities in the US.

Cxbladder’s clinical validation is a major milestone, Mr Darling says, as “urologists love the technology as it is easy to use and very accurate” compared to alternatives.

Patients with bladder cancer or pre-cancer symptoms often need to have multiple visits to an urologist. However, a Cxbladder test can be achieved from a urine sample collected at a patient’s home and the sample sent to Pacific Edge for analysis.

“This is a massive market, where there are many challenges to doing business,” Mr Darling says. “But the rewards are phenomenal and it is a great opportunity for our shareholders.”

The shares rose 5.3% to 20 cents on the NZX, valuing the company at $54.9 million.