Bladder test launch nears
United States customers are being primed for the launch of Pacific Edge's diagnostic test for bladder cancer, Cxbladder.
The commercial launch of the bladder cancer test was on track for March 2013, the company said .
That launch was anticipated following successful registration by US regulatory authorities of Pacific Edge's purpose built testing laboratory and the bladder test Cxbladder, in Hershey, Pennsylvania.
Chief executive David Darling said as part of the launch programme, the Dunedin-based company was working with key urologist customers to establish the commercial requirements Cxbladder would need to fulfil.
The company had recently appointed Premier Source as its billing and reimbursement agent.
"The United States is the largest and most comprehensive market for medical products in the world and it is essential that Pacific Edge fully complies with all the commercial and regulatory requirements from the outset,'' Darling said.
"Establishing a presence in the US is not an easy process ... in this regard we have drawn upon the assistance of potential customers in trialling Cxbladder in their clinical setting.''
Pacific Edge recently appointed Jackie Walker to lead the roll out and management of the company's diagnostic business in the United States, and was now in the process of making further senior appointments to build the sales and marketing team.
"We are now confident that the core elements are either in process or are in place to launch Cxbladder in the US in March 2013,'' Darling said.
International clinical trials had shown that Cxbladder was highly reliable in identifying 100 per cent of late-stage tumours and 95 per cent of high-grade tumours in those patients with haematuria or blood in urine, he said.
Expenses associated with the commercialisation and impending launch of Cxbladder into the US and the establishment of licensing agreements for Australia, Spain and Portugal and for Auckland and Northland in the last financial year form a significant component of the investment in the business during the preceding year.
As a result of these investments in product and commercialisation the company reported a $4.08 million loss for the 2011 financial year.
"The transformation of Pacific Edge from a research and development focus to a world leading molecular cancer diagnostics company is under way," Darling said.
"Funds raised by way of a rights issue last year are underpinning this transition and we believe should provide the required buffer until tangible revenues are received from, New Zealand, Australia, Spain and most importantly, the US."
Pacific Edge is forecasting more than $100 million of annual gross revenues from its United States operations in the fifth years of trading after its Pennsylvania laboratory opens.
Pacific Edge will hold its annual shareholders meeting in Dunedin on August 23, 2012.