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Cancer Dx Firm Pacific Edge Achieves CLIA Registration to Offer Bladder Cancer Test in US

NEW YORK (GenomeWeb News) – New Zealand cancer diagnostics company Pacific Edge said today its US Laboratory has achieved registration under the CLIA regulatory process, setting the stage for it to offer its bladder cancer test in the US.

CLIA registration means that Pacific Edge's laboratory in Hershey, Penn., will be able to operate and process urine samples from patients in the US for its laboratory-developed test called Cxbladder. The non-invasive, urine-based test uses molecular signatures to identify the presence of bladder cancer tumors.

In addition to the US, Cxbladder is available in Australia and New Zealand, and the firm anticipates making the test commercially available in Spain soon. Pacific Edge has licensing deals with Oryzon in Spain and Healthscope in Australia for the test.

According to Pacific Edge CEO Jackie Walker, CLIA registration marks the transition of the test to full commercialization mode. The firm has the core of its sales and marketing team in the US in place and is working with urologists on incorporating Cxbladder into their practices. During the coming months, additional sales and marketing personnel will be added, the company said.

Based in Dunedin, New Zealand, Pacific Edge develops diagnostic and prognostic technologies directed at cancer detection and monitoring.