Cancer specialist Pacific Edge had joined an elite group of organisations outside the United States with the registration of its Dunedin laboratory to conduct tests under US rules, chief executive David Darling said yesterday.
Clinical Laboratory Improvement Amendments (CLIA) sets standards and issued certificates for clinical laboratory testing of laboratory developed tests in the US.
It was administered by the US government agency, Centres for Medicare and Medicaid Services. Dr Darling said only one other laboratory in Australia or New Zealand was understood to have CLIA registration.
Most CLIA -registered laboratories operated in the US and its associated territories.
Registration of the Dunedin diagnostics laboratory complemented the company's purpose built and CLIA-registered facility at Hershey, Pennsylvania. Hershey gained its CLIA registration in March 2013, allowing Pacific Edge to launch Cxbladder commercially in the US in July.
''There are several advantages that arise. First, this level of accreditation for a New Zealand laboratory enhances the overall quality of professional service and quality practised on our bladder cancer tests and secondly, we now have a high quality back-up facility operating at international standards for our global business.''
If there was a major environmental issue in the US that disrupted operations at the Hershey laboratory, Pacific Edge could now provide clinicians and patients there the security of still delivering the tests promptly, he said.
''This is a further significant step for Pacific Edge in the commercialisation of Cxbladder. The CLIA regulatory registration of the Dunedin laboratory has eliminated a major strategic risk from our business. It also provides the company with additional flexibility, as the demand for Cxbladder builds in the US.''
The Dunedin laboratory also had the capacity to cope with any unexpected surge in the demand for Cxbladder tests beyond Hershey's capability of processing up to its design capacity of about 4000 tests a week, Dr Darling said.
At a glance
Cxbladder is a quick, cost-effective, non-invasive and highly accurate diagnostic test enabling clinicians to detect urothelial carcinomas, including cancers of the bladder.
