2 October 2013
US accolade with accreditation granted to Pacific Edge NZ Laboratory
Cancer diagnostic specialist Pacific Edge has joined an elite group of organisations outside the United States with the
registration of Pacific Edge Diagnostics’ Dunedin laboratory to conduct Cxbladder tests under the CLIA regulatory
process.
CLIA registration is mandatory for any laboratory processing Laboratory Developed Tests (LDT) with samples originating
from patients within the United States or its territories.
Pacific Edge Chief Executive Officer, David Darling, says registration of the Dunedin laboratory complements the
Company’s purpose built and CLIA registered facility at Hershey, Pennsylvania in the USA. There are several advantages
that arise; first, that this level of accreditation for a New Zealand laboratory enhances the overall quality of
professional service and quality practiced 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, for example, there is any major environmental issue in the United States that disrupts operations at the Hershey
laboratory, we can now provide clinicians and patients there the security of still delivering test results promptly.
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 United States.” The Dunedin laboratory
also has 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 approximately 4,000 tests per week.
Cxbladder is a quick, cost effective, non-invasive and highly accurate diagnostic test that enables clinicians to detect
urothelial carcinomas including cancers of the bladder.
The Company’s Hershey based laboratory gained CLIA registration in March 2013 enabling Pacific Edge to launch Cxbladder
commercially in the United States in July. Currently, the Dunedin laboratory processes samples obtained from patients in
New Zealand as well as all samples for clinical or in market studies and User Programmes.
CLIA or the Clinical Laboratory Improvement Amendments sets standards and issues certificates for clinical laboratory
testing of Laboratory Developed Tests (LDT) in the United States. It is administered by the US government agency, Centre
for Medicare and Medicaid Services, CMS. Only one other laboratory in Australasia is understood to have CLIA
registration with most CLIA registered laboratories operating in the United States and its associated territories.
ENDS