The commercial launch in the US of the non-invasive test for bladder cancer was now being anticipated after successful registration by the Clinical Laboratories Improve Amendment Act (CLIA) of the company's purpose-built testing laboratory in Hershey, Pennsylvania.
As part of the launch programme, the company was working with key urologist customers to establish the commercial requirements Cxbladder would need to fulfil, he said.
Pacific Edge had recently appointed Premier Source as its billing and reimbursement agent and surveyed chief medical officers from several large private payor companies to ensure the reimbursement system would meet the criteria of their systems.
"The US is the largest and most comprehensive market for medical products in the world, and it is essential Pacific Edge fully complies with all the commercial and regulatory requirements from the outset."
Establishing a presence in the US was not an easy process. It took time to fully understand the many layers and relationships of the commercial and regulatory requirements. In that regard, Pacific Edge had drawn upon the assistance of potential customers in trialling Cxbladder in their clinical settings, Mr Darling said.
He was "delighted" to have a key urologist using Cxbladder in a clinical programme and he expected to have other key urologists actively engaged before the new laboratory was completed in the US.
To do that, Pacific Edge in New Zealand had started on a process of attaining CLIA certification for the Dunedin laboratory. Once the regulatory process was completed this year, the company would be able to provide a New Zealand-based commercial service for private customers in the US.
Jackie Walker was appointed to lead the launch and management of the company's diagnostic business in the US and the company was now making further senior appointments in the US 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," Mr Darling said.
Expenses associated with the commercialisation and impending launch of Cxbladder into the US and the establishment of licensing agreements in other markets during the last financial year formed a significant component of the investment in the business during the preceding year.
As a result of those investments in product and commercialisation, the company reported a $4.1 million operating loss for the year ended March 31, he said.
The transformation of Pacific Edge from a research and development focus to a world-leading molecular cancer diagnostics company was under way, Mr Darling said.
Funds raised through the rights issue last year were underpinning the transition and they should provide the required buffer until "tangible revenues" were received from New Zealand, Australia, Spain and, most importantly, the US, he said.
