Pacific Edge, the maker of non-invasive bladder cancer tests, has won US regulatory approval to commercially process test samples from its latest cancer detecting product at its Dunedin laboratory.
Approval and registration with the US regulatory standard, Clinical Laboratory Improvement Amendments, enables the commercial use of its Cxbladder Triage test at its diagnostics laboratory, the company said. Registration is the standard for any "Laboratory Developed Tests" and mandatory for processing any samples from US-based patients.
Pacific Edge is chasing US sales to tap the world's largest healthcare market, where there are more than 10,000 urologists. Bladder cancer, which is highly treatable, is the ninth most common cancer globally and the fourth most for men.
Cxbladder Triage is Pacific Edge's second bladder cancer testing product and the latest to enter the commercial market. It is used to help rule out early stage bladder cancer by testing patients who have had haematuria (blood in the urine).
Earlier this year, the company was forced to revise its annual loss to $11.2 million for the year ended March 31 to include a $500,000 compensation payment to shareholders following an investigation by the Financial Markets Authority that found the company probably breached NZX listing rules on continuous disclosure.
