Cancer diagnostic specialist Pacific Edge has achieved a major milestone with notification that its commercial laboratory in Hershey, Pennsylvania, has gained registration under the CLIA[1] regulatory process clearing the way for the launch of Cxbladder in the United States.

Specifically,  CLIA¹ registration now enables Pacific Edge’s US laboratory to operate and provide commercial services to clinicians and process urine samples from patients in the United States for its Laboratory Developed test (LDT) Cxbladder. Chief Executive Officer David Darling says CLIA registration is a very significant commercial milestone for the Company and has been achieved within the expected time-frame and budget.

“This progress is great news for all stakeholders and tremendous recognition for the Pacific Edge US and NZ teams who have made this happen in such a professional and expedient manner. The US is the world’s largest healthcare market and the most important market for Cxbladder. The Company now has a commercial capability to reach its prime customer base.”

Jackie Walker, the Chief Executive Officer of Pacific Edge’s US subsidiary Pacific Edge Diagnostics USA (PED_USA) says CLIA registration signals the transition to a full commercialisation phase enabling us to roll-out our sales and marketing program over the next few months for Cxbladder our non-invasive diagnostic test for bladder cancer.

“Cxbladder can now be offered by US clinicians to patients with reimbursement by medical insurers and patients’ ‘out of pocket payment’. Bladder cancer has the highest total medical costs of any cancer, at approximately $US200,000 per patient over the full course of the disease. The Cxbladder test offers significant cost benefits to insurers as well as increasing the ease and comfort for patients.”

Pacific Edge already has the nucleus of its sales and marketing team in place in the United States and has been working progressively with leading urologists on the application of Cxbladder to their clinical practice. Further appointments to the sales and marketing team will be made over the next few months. CLIA registration of the PEDUSA facility follows the recent publication in the prestigious Journal of Urology of the peer reviewed scientific paper on Cxbladder’s clinical study performance.

Urine samples collected by the urologist for Pacific Edge’s proprietary test will now be shipped to the state-of-the-art laboratory in Hershey, Pennsylvania, for processing and analysis to detect the molecular indicators of tumours in the bladder.

“Cxbladder is already attracting keen interest from clinicians and bladder cancer patients who have become aware of the test and its performance, providing them an opportunity for a greater resolution of their disease. The simple urine sample collection process is also seen by many patients as a means of escaping some of the invasive and discomforting testing regime they currently endure. These patients will welcome the introduction of Cxbladder in the US and are expected to encourage their clinicians to adopt it,” Jackie Walker says. Patients diagnosed with bladder cancer need to undergo regular testing for up to five years following initial diagnosis and treatment, much of which is invasive and expensive.

Even so, Pacific Edge expects a gradual take up of Cxbladder in the US and in Australia, New Zealand,  where it is also now available. Cxbladder is expected to be commercially available in Spain soon as well.

“Cxbladder’s sales in the US will have minimal impact on Pacific Edge revenues in this current financial year as we bring the sales and marketing resources to bear and invest strongly in getting the message and product out to the clinicians. Revenue from the US is expected to develop over 2013 as our sales teams build relationships with clinicians. We will be launching with a  new web site and a US specific marketing strategy. This is an exciting time and a great growth opportunity for a New Zealand company and is anticipated to be the gateway to a strong revenue performance for Pacific Edge. ” David Darling says.

“The United States is the largest and most important healthcare market in the world. Its complexity is challenging but Pacific Edge is confident that in PED_USA it has the people at board, executive and technical levels with the depth of experience in launching biomedical products in the United States. This will ensure that clinicians, patients and health funding agencies are fully aware of Cxbladder and its abilities to detect bladder cancer. The capability to build this business opportunity in the US off the back of the New Zealand business has been a significant factor in enabling this market channel to be delivered quickly and very cost-effectively”

The launch of Cxbladder in the United States follows licensing agreements with Oryzon in Spain for Spain (Spain having the highest incidence of bladder cancer in the world), and  Healthscope in Australia. Urologists and general practitioners in New Zealand and Australia are also showing keen interest in using Cxbladder, with a number of them undergoing an in-practice evaluation of Cxbladder to determine how  Cxbladder can best work in their practices. Cxbladder is expected to be widely used as an adjunct to cystoscopy for patients presenting with haematuria and returning to the clinic for on-going monitoring.

[1]The Clinical Laboratory Improvement Amendment, CLIA, sets standards and issues certificates for clinical laboratory testing in the United States. It is administered by the US Centre for Medicare and Medicaid Services, CMS.