Pacific Edge is waiting for US regulatory approval so it can begin staffing its new $4.5 million laboratory in Hershey, Pennsylvania. The lab has the capacity to employ up to 100 staff in sales, administration and the laboratory and to process up to 260,000 non-invasive bladder cancer tests annually.
During the past six months, Pacific Edge shares have steadily risen from 24c to hit 79c, albeit on light trading volumes. Its closing price, at 72c per share, gave it a $200.7 million market capitalisation.
Last week, Pacific appointed a New Zealand and Australia commercial manager, Brent Pownall, and yesterday announced the appointment of a non-executive director, Bruce Nogales, to its US subsidiary .
Chief executive David Darling was contacted in Dunedin yesterday, and said final regulatory approval, registration under the US' Clinical Laboratory Improvement Amendments regulations, had not yet been given, but he was confident it would come through this month, as forecast last year.
''We're at the point where we're ready to put the hammer down,'' Mr Darling said.
When approval came through, he said, sales teams would immediately visit the top 20 urologist sites around the US, each of which employs 10 to 20 urologists, while there would also be appointments of a national sales and strategic accounts representatives, the latter covering institutions and hospitals.
While Pacific Edge has booked total losses of more than $25 million since listing, it recapitalised by more than $20 million in 2011 to fully develop and market its diagnostic Cxbladder test.
Craigs Investment Partners broker Peter McIntyre said investor interest had been spiked with the US operations ''coming to fruition'' and the company's potential to begin making money given the large market it was about to operate in.
''Pacific Edge has been truly the outstanding performer in the market during the past six months,'' he said of its share price, which has risen about 230% during that period.
