Quality Assurance
Our laboratories are committed to a high standard of quality assurance within our operation
New Zealand
Our Cxbladder urine sampling system 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.
Certification
CLIA Certificate of Compliance (99D2064747)
ISO15189:2012 Accreditation (IANZ)
CDPH Clinical and Public Health Laboratory Licence
Clinical Laboratory Permit - Pennsylvania
Clinical Laboratory License - California
Clinical Laboratory Permit - Maryland
Clinical Laboratory License - Rhode Island (Out of State)
Clinical Laboratory Certificate of Compliance - CMS
Pacific Edge Ltd Quality Management System ISO 9001:2015 Certification
USA
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).
The laboratory in Hershey also holds a number of State licenses e.g. New York State, which ensures that specific requirements for testing samples originating from those States are met or exceeded.
Licenses and Certifications
Australia
Our first commercialized product Cxbladder is compliant with the Australian Regulatory Board Therapeutic Goods Administration (TGA) and was registered in 2010.