Crucial regulatory approval has been gained in the United States by listed Dunedin cancer-diagnostic company Pacific Edge, which will allow it to begin operating its $4.5 million laboratory in Pennsylvania.
Satisfying clinical laboratory improvement amendment regulations, which govern clinical lab testing in the United States, allows Pacific Edge to complete its laboratory staffing and begin offering services to clinicians.
Pacific Edge estimates it could be turning over $100 million a year in the United States within five years. Investors include the family of Peter Masfen, The Warehouse founder Sir Stephen Tindall and Dunedin sharebroker Eion Edgar.
Pacific Edge is targeting a large number of urologists in the US with its non-invasive bladder cancer Cxbladder test. Chief executive David Darling said the registration was a ''milestone'' for Pacific Edge, and was achieved on time and on budget.
''The US is the world's largest healthcare market and the most important market for Cxbladder,'' Mr Darling said in a statement yesterday.
Pacific Edge shares last week hit an eight-year high of 79c, but were down at 74c after the announcement yesterday. At full capacity, the Pennsylvania laboratory could employ up to 100 people and carry out 260,000 tests annually.
