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.

ends

© Scoop Media

 
 
 
 
 
Culture Headlines | Health Headlines | Education Headlines

 
Sheep: Shearing Record Smashed In Hawke’s Bay

Three shearers gathered from around New Zealand have smashed a World record by 264 sheep despite the heat, the pumiced sheep of inland Hawke’s Bay and a year’s wool weighing an average of over 3.5kg a sheep. More>>

ALSO:

Carrie Fisher: Hollywood In-Breeding & The Velocity Of Being - Binoy Kampmark

There was always going to be a good deal of thick drama around Carrie Fisher, by her own confession, a product of Hollywood in-breeding. Her parents, Debbie Reynolds and the crooner Eddie Fisher, provided ample material for the gossip columns in a marriage breakup after Eddie sped away with Elizabeth Taylor. More>>

  • Image: Tracey Nearmy / EPA
  • Gordon Campbell: On The Best Albums Of 2016

    OK, I’m not even going to try and rationalise this surrender to a ‘best of’ listicle. Still…maybe there is an argument for making some semblance of narrative order out of a year that brought us Trump, Brexit and the deaths of Prince, David Bowie, Leonard Cohen and Alan Vega, who I missed just as much as the Big Three. So without further ado….oh, but first a word from the sponsor More>>

    Emojis: World’s First Māori Emoji App Launched

    It’s here - the world’s first Māori emoji app Emotiki has landed just in time for summer roadtrips and santa stockings, with 200 Māori and Kiwi cultural icons for people to share their kiwiana moments with each other and the world. More>>

    ALSO:

    Howard Davis: Album Of The Year - Van Morrison's 'Keep Me Singing'

    2016 was a grand year for Van The Man - The Belfast Cowboy turned 71, received a knighthood, and reissued an expanded set of soul-fired live recordings from 1973 ('It's Too Late to Stop Now'). In the game for 53 years now, Morrison's albums consistently open new windows into the heart and soul of one of the most enigmatic figures in modern music. More>>

    Review: The NZSO Performs Handel's Messiah

    Max Rashbrooke: Saturday night's performance took the piece back to something like the way it would have originally been performed when premiered in 1742, with an orchestra of 20-30 players and only a few more singers. More>>

    Culture: Rare Hundertwasser Conservation Posters Found After 40 Years

    When Jan and Arnold Heine put a roll of conservation posters into storage in 1974 they had no idea that 42 years later they would be collectors items. More>>

    Get More From Scoop

     
     

    LATEST HEADLINES

     
     
     
     
    Health
    Search Scoop  
     
     
    Powered by Vodafone
    NZ independent news