Pacific Edge cancer tests approved
By Suze Metherell
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 commercial use of its Cxbladder Triage test at its diagnostics laboratory, the company said in a statement.
Registration is 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).
The firm is also expanding beyond bladder cancer testing.
Last September it announced it was looking to commercialise its Cxcolorectal test in Japan, where colorectal cancer is the nation's most prevalent cancer.
The test, which is in the late stages of development, will detect aggressive cancer in patients who have already been diagnosed, which means doctors are able to target the disease with more specific treatment.