Pacific Edge’s New Zealand laboratory gains CLIA approval for Cxbladder Triage test
Cancer diagnostic specialist Pacific Edge today advised it has gained regulatory approval from the USA regulatory authority CLIA (Clinical Laboratory Improvement Amendments) to enable the commercial use of its Cxbladder Triage test from its diagnostics laboratory in Dunedin.
The approval from CLIA is the registration standard for any laboratory processing of Laboratory Developed Tests (LDT). This is mandatory for processing any samples originating from patients within the United States or its territories.
Pacific Edge Chief Executive Officer, David Darling, says: “This is an important step for the commercial application of Cxbladder Triage.The approval means that Cxbladder Triage test samples can now be commercially processed at our Dunedin laboratory and offered to markets that recognise the CLIA regulatory approval. It also complements the approval we have gained for the Cxbladder Detect test.”
Cxbladder Triage is Pacific Edge’s newest product to enter the commercial market and offers physicians an accurate test to triage out those patients who present with haematuria who have a low probability of having urothelial carcinoma.
The Dunedin laboratory processes samples obtained from patients in New Zealand as well as all samples for clinical or in market studies and User Programs.
CLIA 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 believed to have CLIA registration with most CLIA registered laboratories operating in the United States and its associated territories.« Back