20 Mar 2013

NZ firm gets US approval to sell cancer test

7:45 pm on 20 March 2013

Cancer diagnostic specialist Pacific Edge is expecting to make $100 million in five years after clearance from US regulators to sell its bladder cancer test.

The Dunedin company says the Clinical Laboratory Improvement Amendment (CLIA) registration for its Pennsylvania laboratory is a major milestone, achieved ahead of time and below budget.

Registration allows the laboratory to operate and provide commercial services to clinicians.

It will process urine samples for bladder cancer, a non-invasive method that's cheaper than current tests.

Pacific Edge chief executive David Darling says a sales team will start next month and the company will start making money in the US later this year.

Mr Darling says Pacific Edge, which started developing the bladder cancer test 10 years ago, has spent $3 million setting up in the US, keeping costs down by continuing to operate from New Zealand.

The company is 60% owned by 20 individuals including Sir Stephen Tindall and Eion Edgar.