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
''The US is the world's largest healthcare market and the
most important market for Cxbladder,'' Mr Darling said in a
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.