NZX ANNOUNCEMENT: Released 18 October 2013

Cancer diagnostic specialist Pacific Edge (NZX:PEB) is delighted to announce that it has completed the first commercial sales of Cxbladder tests signalling the start of the commercial revenue for the company in the US. The tests were ordered by US based clinicians and processed in Pacific Edge USA (PEDUSA)’s custom laboratory in Hershey Pennsylvania.

Earlier this week Pacific Edge finalised an agreement with national preferred provider network, FedMed to enable 40 million Americans to have access to Cxbladder. Negotiations are also underway with other national provider networks to broaden the access to Cxbladder

The commercial relationship with FedMed provides FedMed’s contracted insurance carriers, third party administrators, health and welfare funds, and self-insured health plans with access to Cxbladder.  More than 40 million Americans have access to FedMed’s National Provider Network of over 550,000 physicians, 4,000 hospitals and 60,000 ancillary care providers nationwide.

The commercial rollout of Cxbladder in July followed certification of the purpose built and equipped molecular diagnostic, CLIA approved, laboratory in Hershey.

PEDUSA Chief Executive Officer Jackie Walker says “the laboratory, custom built for high throughput testing with the design capacity to process up to 4000 tests per week, is achieving the design expectations and the processing of patient samples is exceeding the prompt turnaround times expected by clinicians delivering on our brand promise”.

“Our US sales and marketing team have segmented the market to focus the sales force and resources on the clinicians who are treating the largest number of bladder cancer patients. This includes large commercial payers and the Centre of Medicare and Medicaid Services, (CMS), which  provides healthcare for 100 million people  or nearly a third of the American population.   Other key sales targets include the Veterans Administration (VA), Health Maintenance Organisations (HMOs) and Large Urology Groups (LUGS)  who are the point of contact for many patients presenting with hematuria (blood in the urine) which is an early indicator of possible bladder cancer,” says Jackie Walker.

More than one million Americans will have undergone medical investigation this year for possible bladder cancer at an estimated cost of $US1 billion. Bladder cancer is one of the most expensive cancers to treat with regular testing required over a five year period after the initial diagnosis. With the very high recurrence of this disease some patients are receiving expensive monitoring for the rest of their life giving rise to bladder cancer having the highest total medical costs of any cancer from detection to death, approaching $US220,000 per patient in the USA.

The US team is building on the experience gained with User Programs and studies undertaken with leading urologists in a number of countries to improve the understanding by clinicians of the effectiveness of Cxbladder and its ability to detect urothelial carcinomas.

Pacific Edge Chief Executive Officer David Darling says the building blocks are in place to achieve commercial success in the US, the world’s largest health market. “We are now starting to work with leading patient advocacy groups create patient awareness to compliment the growing uptake by clinicians.

“With Cxbladder available to patients in New Zealand, Australia and now the US, patients who have cancer quickly become very aware of the long road of care management that is likely to be needed in their disease management and the extensive and invasive nature of the disease monitoring process. As they gain an understanding of Cxbladder and its non-invasive urine sample process they are becoming strong proponents of our test,” David Darling says.

“We are confident that the outstanding performance of Cxbladder as a highly efficient cancer detection test and its patient friendly sample collection technology will be endorsed by clinicians and patients in the US and other markets we target.”

Evidence of that is already being demonstrated in New Zealand, where Pacific Edge is negotiating with health boards (DHBs) to follow the lead of the signing of MidCentral DHB to use Cxbladder as a cost effective means of triaging patients presenting with micro hematuria.

Cxbladder is being made available to clinicians and their patients in Australia by Healthscope, the country’s largest provider of private healthcare. Soon it will made available by Oryzon to residents of Spain, the country with the highest incidence of bladder cancer in the world.