Our laboratories are committed to a high standard of quality assurance within our operation
Our first commercialised product Cxbladder is compliant with the New Zealand Medical Device Database (WAND) and was registered in 2011.
In October 2013, Pacific Edge Diagnostics NZ’s (PEDNZ) laboratory obtained registration to conduct Cxbladder tests under the CLIA regulatory process. This registration enables PEDNZ to process samples originating from patients within the United States or its territories in order to complement PEDUSA's purpose built and CLIA registered facility.
In May 2015, the PEDNZ laboratory also achieved its ISO accreditation status, from the International Accreditation New Zealand (IANZ) for the International Standard, ISO 15189:2012 for Medical Laboratories.
The Clinical Laboratory Improvement Amendments (CLIA) sets standards for clinical laboratories in the United States. Under this system, the United States Centers for Medicare & Medicaid Services (CMS) administers the law and provides certificates to clinical laboratories to ensure they comply with all legal requirements.
Pacific Edge Diagnostics USA’s (PEDUSA) laboratory holds a Certificate of Compliance from CMS. This compliance allows PEDUSA’s laboratory to provide commercial services to clinicians and process urine samples from patients in the United States for our Laboratory Developed Test (LDT, Cxbladder).
Licenses and Certifications
Our first commercialised product Cxbladder is compliant with the Australian Regulatory Board Therapeutic Goods Administration (TGA) and was registered in 2010.
In preparation for the launch of Cxbladder in Spain through our commercial partner Oryzon, applications for CE Mark registration and compliance are currently underway.