PEL to feature in New Zealand Inc booklet developed by NZTE & MFAT

NZTE Media Writer, Katherine Edmond used Pacific Edge Limited as a case study "demonstrating the learnings and experiences of New Zealand businesses exporting to or operating in the United States."

Pacific Edge Limited

It took three years immersion in the United States market place and regulatory environment for cancer biomedical company Pacific Edge (PEL) to develop a sustainable business plan for market entry.

Based in Dunedin, Pacific Edge is a publicly listed company that specialises in the discovery and commercialisation of diagnostic and prognostic technology for cancer detection and management. Its first United States franchise to market its bladder cancer detection test, Cxbladder, is due to open in early 2013.

The US was always on the company's radar says CEO David Darling. "It's the world's largest healthcare market and it understands our field. Molecular diagnostic systems have had longer exposure there, and there are more examples in commercial use, than anywhere else."

But finding a route in, and a niche once there, was challenging - no other New Zealand business had done it quite the same way so Pacific Edge had to figure it out for itself.

Darling says the company talked to American businesses, went to conferences, networked, and invested in hiring good US consultants in specialist areas.

Getting healthcare products approved for the US market is often requires regulatory approval by the US Food and Drug Administration (FDA), which is notoriously slow and expensive. Instead, for tests such as Cxbladder, companies can follow the CLIA (Clinical Laboratory Improvement Amendments) route, an alternative regulatory pathway which sets and monitors standards for clinical laboratory testing.

"There wasn't anyone in New Zealand who knew anything substantive about the CLIA regulatory pathway - it was only by spending a lot of time in the US that we came to understand how CLIA works, where we fitted, and how it could be utilised in our business plan for the US."

The next step was finding urologists to champion the companyäó»s product and build a presence on the ground. Pacific Edge has eight leading urologists, four in the US, two in Australia and two in New Zealand, heading up its Clinical Advisory Board.

Pacific Edge has opted to establish its office and processing facility for Cxbladder tests at Pennsylvania research facility Hershey Centre for Applied Research (HCAR).

"Strategically the smart place to be, it's within a couple of hours of big population centres like New York and Washington and 20 minutes from the largest Fedex hub in the United States, which helps with delivery of samples from around the country," says Darling.

Pacific Edge is also benefitting from HCAR's commercialisation experience and connections.

"They have helped us understand the marketplace and the needs of our top prospects and we can leverage off the strategic partnerships they have with other organisations in Pennsylvania. We are well supported at the State level to implement our business plan."