The company's flagship product, Cxbladder, has received registration under the Australian regulatory body Therapeutic Goods Administration (TGA), permitting Pacific Edge and its Australian partner, Healthscope, to market and sell the product to all segments of the Australian market.
"We are very excited about the news," chief executive David Darling said. "Healthscope is a big, powerful and exciting partner for the Australian market, but the TGA registration is a crucial part of that process."
Cxbladder is a non-invasive, accurate test that enables the early detection of bladder cancer from a small volume of urine.
Pacific Edge recently signed a licensing agreement with Healthscope, which is Australia's second-largest private hospital provider operating 44 private hospitals.
Healthscope also is a leading pathology business provider, with facilities in Australia, New Zealand, Singapore, Vietnam and Malaysia. It has a growing medical centres division, with more than 48 clinics and a diagnostic imaging division centred in major hospitals.
There are about 300 urologists in Australia and New Zealand, of whom 240 are resident and practising in Australia. In Australia, 50,000 people presented each year with hematuria, or blood in the urine.
The company had earlier signed a license agreement with Spain's Oryzon SA, a specialist diagnostics company.
Spain has the highest incidence of bladder cancer per head of population worldwide. In Spain and Portugal, about 200,000 people a year present with hematuria.
However, the United States was still the prize market being sought by Pacific Edge, Mr Darling said. In the US, there were one million people presenting with early signs of bladder cancer and 17,000 urologists.
"It's a very big market for us.
I can't go into the details, but the retail price of the product will be high. It is a big prize for the company.
"Australia, Spain, Portugal and the US are underwriting the future of the company."
Mr Darling said the registration in Australia represented an important milestone in the company's programme of commercialisation.
Regulatory approval was a key element in today's healthcare environment to ensure product compliance and allow new products to be effectively and safely used in the market.
Australia was a key market because it was effectively Pacific Edge's home market and enabled the company to get an early start in generating revenue, he said.
In May, Health Minister Tony Ryall opened a $500,000 specialist diagnostic laboratory at Pacific Edge's base within the University of Otago's Centre for Innovation.
Mr Darling said the laboratory model adopted by Pacific Edge had allowed the company to help establish the same model in Spain and now Australia. It would also help establish laboratories quickly in the US.
Treatment of bladder cancer incurred the highest medical costs of any cancer, and in the US the figure was approaching $US200,000 ($NZ243,000) per patient from detection until death.
The Australian healthcare system was expected to invest more than $50 million a year in investigating hematuria.
Cxbladder was expected to completely replace cytology and be used to complement cystoscopy in the clinical care of patients presenting with hematuria, he said.
