News Video | Policy | GPs | Hospitals | Medical | Mental Health | Welfare | Search


Pacific Edge’s US laboratory receives CLIA registration

18 March 2013
Pacific Edge’s US laboratory receives CLIA registration for Cxbladder

Cancer diagnostic specialist Pacific Edge has achieved a major milestone with notification that its commercial laboratory in Hershey, Pennsylvania, has gained registration under the CLIA1 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 (PEDUSA) 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 performence.

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 PEDUSA 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 inpractice 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.


© Scoop Media

Culture Headlines | Health Headlines | Education Headlines


13/10: 40 Years Since The Māori Land March Arrived At Parliament

Traffic into Wellington came to a standstill as thousands of Māori and Pākehā streamed along the motorway into the capital on 13 October 1975, concluding the Māori land march to parliament. More>>


Scoop Review Of Books: Before The Quakes

Remembering Christchurch: Voices from decades past: The Christchurch I lived in for my first 23 years was where four-year-olds walked alone to kindergarten, crossing roads empty of all but a couple of cars per hour. My primary school, Ilam, was newly built on a grassy paddock surrounded by rural land... More>>

6-11 October: New Zealand Improvisation Festival Hits Wellington

Wellingtonians will have a wide selection of improv to feast on with a jam packed programme containing 22 shows, three companies from Australia, two companies from Auckland, one from Nelson, one from Christchurch and seven from Wellington. More>>


Bird Of The Year: New Zealanders Asked To Vote For Their Favourite Native Bird

Te Radar, David Farrier, Heather du-Plessis Allan and Duncan Garner are just some of the New Zealanders championing their favourite native bird in Forest & Bird’s annual Bird of the Year competition, which kicks off today.. More>>


Werewolf Film: It Follows - Panic In Detroit

Philip Matthews: When you heard last month that Wes Craven had died and you wanted to pay homage, you could have sat down with any one of five of his films that helped reinvent American horror at least three times over three decades... Or you could just have watched one of the greatest recent horror films that would probably not exist without Craven. More>>


Werewolf Music: Searching For The White Wail - On Art Pepper, etc

If the word ‘hipster’ means anything – which it arguably doesn’t – it seems to be more of an impulse than a condition. One always headed for the margins, and away from the white-bred, white-bread mainstream... More>>


Get More From Scoop



Search Scoop  
Powered by Vodafone
NZ independent news