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
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.