US Laboratory complete regulatory approval process underway

US Laboratory complete regulatory approval process underway

Cancer diagnostic company Pacific Edge Limited has completed its US$3.7 million laboratory in the United States on-schedule and within budget and is now preparing for registration under the Clinical Laboratory Improvement Amendments (CLIA) regulations.

The purpose-built laboratory in Hershey, Pennsylvania is expected to complete regulatory approval and be fully operational in March 2013 to offer Pacific Edge's bladder cancer diagnostic test, Cxbladder, as a Laboratory Developed Test (LDT) to clinicians throughout the United States. The laboratory, with a capacity of 260,000 tests a year, will be operated by a wholly owned subsidiary of the company, Pacific Edge Diagnostics USA Limited (PEDUSA).

Pacific Edge Chief Executive Officer David Darling says, "the demanding timetable to launch this business is being met and the focus of the US team led by Jackie Walker is now on completion of the regulatory approvals, sales force deployment and marketing roll-out."

"There is a growing awareness amongst bladder cancer patients and their clinicians of Cxbladder, its ease of use, non-invasiveness and its ability to effectively detect bladder tumours. This awareness has been further advanced by publication in the September 2012 edition of the US Journal of Urology of the peer reviewed paper on clinical tests of Cxbladder."

"The United States is the world's largest healthcare market. This coupled with the 17,000 urologists practising there makes the US the most important market for Pacific Edge and our cancer detection and management products. In the US over one million people annually present to their medical specialist with haematuria (blood in the urine) this gives rise to a total cost in excess of US$ 1 billion to identify patients with bladder cancer, so there is a major opportunity to provide a better and more cost effective solution. Integrating Cxbladder into the clinical pathway offers an effective detection tool to complement existing clinical work-up; relieves patients from some of the invasive testing and monitoring regimes and gives health insurers a lower overall cost opportunity."

"Jackie Walker has considerable experience in the commercialisation of medical devices in the United States and is putting together an experienced team to launch Cxbladder to the medical community."

PEDUSA's Pennsylvania location is close to leading medical research and hospital facilities, cancer institutes and from a logistics perspective, a national courier hub which will be important for the rapid delivery of test samples to the laboratory for initial testing. Pacific Edge has a fully funded budget to provide for the staffing and operations of PEDUSA.

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