NEW YORK (GenomeWeb) –New Zealand cancer diagnostics firm Pacific Edge today said that its Dunedin-based laboratory has received ISO 15189:2012 accreditation, expanding its international business opportunities.
The accreditation was carried out by International Accreditation New Zealand. The accreditation is a "formal recognition" of technical competence, and the process includes an annual on-site evaluation of the company's quality management system and competency in staff, methods and equipment, testing, and quality control, Pacific Edge said.
Pacific Edge Diagnostics NZ Quality Manager Lisa Cambridge said in a statement that the accreditation "provides us with national and international quality recognition and will complement" the CLIA accreditation that the Dunedin facility has already received.
The firm's US laboratory in Hershey, Pennsylvania also received CLIA registration in 2013.
Pacific Edge CEO David Darling said that the firm remains focused on building momentum in the US, where it is now in its second year of commercial operations and has 12 dedicated sales staff.
"Laboratory throughput continues to track to the company's expectations following an active direct sales and marketing program to clinicians and healthcare organizations," he said.