Video | Agriculture | Confidence | Economy | Energy | Employment | Finance | Media | Property | RBNZ | Science | SOEs | Tax | Technology | Telecoms | Tourism | Transport | Search


US accolade with accreditation granted to Pacific Edge NZ

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.


© Scoop Media

Business Headlines | Sci-Tech Headlines


Air New Zealand: Employees Recognised With $1,000 Share Award

The efforts Air New Zealand employees made during one of the airline’s toughest years will be recognised via an award of $1,000 worth of company shares to all permanent employees... More>>

Consumer NZ: Bank Complaints On The Rise, Survey Shows

Nearly one in five Kiwis had a problem with their bank in the past year, Consumer NZ’s latest satisfaction survey finds. Consumer NZ chief executive Jon Duffy said the number of bank customers reporting problems had jumped to 18%, up from 11% in 2020... More>>

Federated Farmers: Applauds UK-Australia Free Trade Deal

News that Australia and the UK have signed a free trade agreement is a promising step forward in the fight against tariffs and protectionism, Federated Farmers says.
"It reinforces the international rules-based trading framework and is important for rural producers and global consumers," Feds President Andrew Hoggard says... More>>

ASB: New Zealanders Missing Out On Hundreds Of Millions In KiwiSaver Government Contributions

New Zealanders have just over a week to ensure they’re eligible for the maximum annual government KiwiSaver contribution... More>>

Stats NZ: GDP Climbs 1.6 Percent In March 2021 Quarter Following December Dip

Gross domestic product (GDP) rose by 1.6 percent in the March 2021 quarter, following a 1.0 percent fall in the December 2020 quarter, Stats NZ said today. "After an easing of economic activity in the December quarter, we’ve seen broad-based growth in the first quarter of 2021... More>>

Reserve Bank: Debt Serviceability Restrictions Added To Policy Toolkit

The Reserve Bank – Te Pūtea Matua and the Minister of Finance have agreed to update their shared Memorandum of Understanding (MoU) on macro-prudential policy and add debt serviceability restrictions to the list of potential tools available... More>>