Pacific Edge seeks additional laboratory accreditation as it pursues international opportunities
NZX-listed Pacific Edge today confirmed that it was seeking accreditation from International Accreditation New Zealand (IANZ) for its Dunedin-based diagnostics operation as it looks to pursue further international commercialisation opportunities for Cxbladder.
The company's Dunedin-based clinical laboratory operation has been successfully assessed by IANZ. Formal approval for Pacific Edge Diagnostics NZ Ltd laboratory is expected to take up to six weeks. The assessment is for the International Standard; ISO15189 : 2012 for Medical Laboratories.
Pacific Edge Chief Executive David Darling said: "Gaining the IANZ accreditation is a very important step for us particularly for the commercial servicing of markets, such as those in South East Asia, using our New Zealand based laboratory."
Pacific Edge Diagnostics NZ Quality Manager Lisa Cambridge said: "Formal accreditation of our technical competency and quality for the New Zealand based laboratory will provide national and international quality recognition and will compliment the USA based CLIA accreditation that has already been gained by our clinical laboratory here in Dunedin. Once obtained we will be able to meet the needs of new commercialisation opportunities that the company may wish to pursue."
The IANZ process assesses and accredits applicants against standards in a number of fields of technology, including those developed by the International Organisation for Standardisation, a worldwide federation made up of 163 member countries who develop international standards.
Accreditation is a formal recognition of technical competency through assessment, including an annual on-site assessment of an organisation's quality management system and competency in technical areas such as staff, methods and equipment, testing and quality control.
David Darling noted that while Pacific Edge continued to look at ways of securing its ground-breaking cancer technology in global markets, its main focus remained on building sales momentum in the US, the world's largest healthcare market. "We are now in our second year of commercial operations there. Laboratory throughput is tracking to the company's expectations following an active direct sales and marketing program to clinicians and healthcare organisations. Pacific Edge Diagnostics USA has twelve dedicated sales executives operating in key geographic regions."