The lab has been completed on schedule and within budget and is now preparing for registration under the Clinical Laboratory Improvement Amendments regulations.
It is expected to be fully operational by March next year.
Dunedin-based chief executive David Darling said completing the regulations was a "significant process", but the company was "well through it" and he hoped for approvals by March next year.
The lab will test Pacific Edge's non-invasive bladder cancer diagnostic tool, Cxbladder, and will have a capacity to process up to 260,000 tests annually. It will be operated by its wholly owned subsidiary, Pacific Edge Diagnostics USA Ltd, headed by recently appointed chief executive Jackie Walker.
While Pacific Edge has accumulated consecutive losses totalling more than $21 million since listing in 2005, in its last trading year to March it raised more than $20 million in private placements and direct share offers, largely to launch into the US market.
Mr Darling said 2012 and 2013 were "the big investment years for us and also to grow the revenue base, which is moving along nicely".
Pacific Edge shares were up 7.5% yesterday, trading around their highs of 43c, giving it a market capitalisation beyond $100 million.
Aside from the US market, Pacific Edge has operations in New Zealand and Australia and Cxbladder is expected to be released in Spain and Portugal this year.
Mr Darling said a new lab in Spain, which would also service Portugal, was expected to be formally launched later this year, with a capacity about four times that of the Dunedin laboratory, and about a fifth of the capacity of the Pennsylvania lab.
Mr Darling expected that within three years the US lab would employ 80 to 100 people, including sales teams operating in other states.
